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sgsystemsglobal · 2 months ago

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Future Trends in Pharmaceutical Traceability Software: Innovations on the Horizon

The pharmaceutical industry is on the cusp of a digital transformation, with emerging technologies reshaping the way companies manage the safety, quality, and traceability of drugs. At the core of this evolution is pharmaceutical traceability software, which allows manufacturers to track and monitor the movement of products and raw materials across the entire supply chain. With growing regulatory demands and the need for better transparency, pharmaceutical companies must keep pace with innovations that enhance product safety and compliance.

In this blog, we’ll explore the future trends in pharmaceutical traceability software that are set to revolutionize the industry, enabling pharmaceutical companies to meet stringent compliance standards like 21 CFR Part 11, improve operational efficiency, and ensure the safety of their products.

Why Traceability in Pharmaceuticals Matters

Before diving into the future trends, it’s crucial to understand why pharmaceutical traceability is so essential. In the pharmaceutical industry, product safety and quality are paramount. Traceability ensures that every batch of drugs can be traced back to its source, from raw materials to the final product. This is not only important for ensuring the integrity of the product but also for managing recalls, reducing counterfeit drugs, and complying with global regulatory standards.

With regulations such as 21 CFR Part 11 Compliance, which governs the use of electronic records and signatures in the U.S. Food and Drug Administration (FDA) regulated industries, pharmaceutical companies are under pressure to implement robust traceability systems. Compliance with this regulation ensures that electronic records are trustworthy, reliable, and equivalent to paper records. Effective pharmaceutical traceability software is essential to achieving this.

Now, let’s look at the future trends that are shaping the next generation of pharmaceutical traceability.

1. Blockchain Technology for Immutable Records

One of the most exciting innovations on the horizon for pharmaceutical traceability software is the integration of blockchain technology. Blockchain’s ability to create a decentralized, immutable ledger makes it a perfect fit for industries that rely on highly accurate, tamper-proof data.

In the context of pharmaceutical traceability, blockchain can provide real-time visibility into the entire supply chain. From sourcing raw materials to tracking the distribution of the final product, every transaction is recorded in the blockchain, making it impossible to alter without leaving a trace. This level of security is particularly important for combating counterfeit drugs, which continue to be a significant issue in the industry.

Moreover, blockchain offers enhanced transparency and can help pharmaceutical companies demonstrate compliance with 21 CFR Part 11. By providing an indelible audit trail, it becomes easier to prove the integrity of electronic records, ensuring that all actions taken in the drug manufacturing and distribution process are traceable.

2. AI-Powered Predictive Analytics for Quality Control

As pharmaceutical batching and production processes become more complex, predictive analytics powered by artificial intelligence (AI) is becoming a critical component of traceability software. AI can analyze vast amounts of data in real-time, identifying patterns and trends that might indicate potential quality issues or inefficiencies in the supply chain.

For example, AI can monitor environmental conditions during drug manufacturing or shipping and predict when deviations might occur that could compromise product quality. This predictive capability allows pharmaceutical companies to address issues before they escalate, ensuring that only safe, high-quality drugs reach the market.

Additionally, AI-driven analytics can optimize pharmaceutical formulation software, which is responsible for ensuring that drug recipes are consistently followed. By analyzing data from previous batches, AI can suggest adjustments to formulations or processes to improve product consistency and quality.

3. IoT Integration for Real-Time Monitoring

The Internet of Things (IoT) is another technology that is poised to enhance pharmaceutical traceability. IoT devices, such as sensors and RFID tags, can provide real-time monitoring of pharmaceutical products as they move through the supply chain. These devices can track important parameters such as temperature, humidity, and location, ensuring that drugs are stored and transported under the right conditions.

For instance, biologics and other temperature-sensitive medications require strict temperature control during transportation and storage. IoT sensors can continuously monitor the temperature, providing real-time alerts if it goes outside the acceptable range. This ensures that any temperature excursions are immediately addressed, preventing potentially harmful products from reaching patients.

When combined with pharmaceutical traceability software, IoT data can be seamlessly integrated into the traceability system, offering a comprehensive view of the product’s journey from production to patient delivery. This not only enhances safety but also aids in regulatory compliance by providing detailed documentation for audits.

4. Enhanced Data Security and Privacy Features

As pharmaceutical companies increasingly rely on digital systems for traceability, data security and privacy are becoming critical concerns. With the rise in cyberattacks targeting healthcare and pharmaceutical companies, traceability systems must evolve to offer robust security features that protect sensitive data.

Future pharmaceutical traceability software will likely incorporate advanced encryption techniques, multi-factor authentication, and AI-driven security measures to detect and respond to potential threats in real-time. These features will ensure that all traceability data, including electronic records required for 21 CFR Part 11 compliance, are protected from unauthorized access or tampering.

In addition, data privacy regulations, such as the General Data Protection Regulation (GDPR) in Europe, place strict requirements on how companies handle personal data. Traceability software will need to incorporate tools that allow pharmaceutical companies to manage data privacy effectively, ensuring that any patient or product information is stored and transmitted securely.

5. Cloud-Based Traceability Solutions for Scalability and Flexibility

Cloud computing is set to play a significant role in the future of pharmaceutical traceability software. Cloud-based traceability solutions offer scalability, flexibility, and cost-efficiency, making them an attractive option for pharmaceutical companies of all sizes.

By leveraging cloud infrastructure, pharmaceutical manufacturers can scale their traceability systems as needed, accommodating growing production volumes or expanding into new markets. Cloud-based systems also offer the advantage of remote access, allowing teams across different locations to access traceability data in real-time.

Moreover, cloud solutions can streamline compliance with 21 CFR Part 11 by providing secure, centralized storage for electronic records and signatures. Cloud platforms are often equipped with advanced compliance features, such as automated audit trails and secure data backups, helping companies ensure that they meet regulatory requirements.

Conclusion

The future of pharmaceutical traceability software is bright, with innovations like blockchain, AI, IoT, enhanced data security, and cloud-based solutions set to transform the industry. These technologies will enable pharmaceutical companies to improve product safety, streamline compliance, and increase operational efficiency.

By adopting these cutting-edge technologies, companies can not only meet the ever-growing regulatory demands but also enhance the integrity of their supply chains, ensuring that patients receive safe and effective medications. As these trends continue to shape the future of pharmaceutical traceability, businesses must stay ahead of the curve to remain competitive and compliant in an increasingly complex global market.

#pharmaceutical traceability software #Pharmaceutical Traceability #21 Cfr Part 11 Compliance #Pharmaceutical Batching

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cssdtechnologies · 5 months ago

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What is 21 CFR part 11 Complaint Software?

21 CFR Part 11 compliant software refers to software systems that adhere to the regulations outlined in Title 21 of the Code of Federal Regulations (CFR), Part 11, which governs electronic records and electronic signatures in the context of the pharmaceutical, biotechnology, and medical device industries regulated by the Food and Drug Administration (FDA) in the United States.

Here are the key components and requirements of 21 CFR Part 11 compliance for software systems:

Electronic Records: The regulation requires that electronic records be trustworthy, reliable, and equivalent to paper records. This includes ensuring the accuracy, integrity, and availability of electronic records throughout their lifecycle.

Electronic Signatures: Part 11 establishes criteria for electronic signatures, ensuring that they are legally binding and equivalent to handwritten signatures. Electronic signatures must be unique to the individual, verifiable, and securely managed to prevent unauthorized use.

Audit Trail: Compliance requires the implementation of an audit trail system to record all actions related to the creation, modification, or deletion of electronic records. Audit trails must be secure, time-stamped, and accessible for review by authorized personnel.

User Authentication and Authorization: Software systems must have robust user authentication mechanisms to verify the identity of individuals accessing electronic records or signing documents. Access controls should be implemented to restrict unauthorized access to sensitive information.

Data Security: Part 11 mandates the implementation of appropriate security measures to protect electronic records from unauthorized access, alteration, or destruction. This includes encryption, data integrity checks, and user access controls to safeguard sensitive information.

System Validation: Software systems subject to Part 11 must undergo validation to demonstrate their reliability, accuracy, and compliance with regulatory requirements. Validation activities typically include testing, documentation, and verification of system functionality.

Record Retention and Archiving: Compliance requires the establishment of procedures for the retention and archiving of electronic records to ensure their long-term preservation and accessibility. Records should be stored in a secure and tamper-evident manner to prevent data loss or corruption.

Training and Documentation: Part 11 mandates training for personnel involved in the use of electronic records and electronic signatures. Additionally, comprehensive documentation must be maintained to support compliance efforts, including standard operating procedures (SOPs) and validation documentation

Software systems that meet the requirements of 21 CFR Part 11 compliance provide pharmaceutical, biotechnology, and medical device companies with the assurance that electronic records and signatures are managed in a manner that meets regulatory standards for data integrity, security, and reliability. Compliance with Part 11 is essential for organizations seeking FDA approval for the use of electronic records and signatures in regulated activities.

Best 21 CFR part 11 Complaint Software Provider in

If you are looking for 21 CFR part 11 Complaint Software provider in India, look no further than Instech Systems, We are a Best 21 CFR part 11 Complaint Software provider in India.

For more details, please contact us!

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#21 CFR part 11 Complaint Software #instech systems #21 CFR part 11 Complaint Software provider in India

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logilablabsolution · 1 year ago

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#21 cfr part 11 #software

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pharmisionbarcodeindia · 2 years ago

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Why Must Pharmaceutical Companies Switch to eLog Management Solutions? - Pharmision Barcode India

According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk. Read more https://pharmisionbarcodeindia.blogspot.com/2023/04/why-must-pharmaceutical-companies.html

#elog #21 CFR Part 11

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ccrpsorg · 2 years ago

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Navigating 21 CFR 312: A Comprehensive Guide

Keeping Up with FDA Regulations and Requirements

What is 21 CFR 312?

21 CFR 312 is a set of regulations and requirements set out by the Food and Drug Administration (FDA). It details the procedures and processes that clinical trials must follow in order to be approved by the FDA. These regulations must be followed in order to ensure that the clinical trial being conducted is safe and beneficial for the participants.

21 CFR 312 is a federal regulation from the Code of Federal Regulations that outlines the requirements for Investigational New Drugs (INDs). This section of the code provides guidance to drug manufacturers and sponsors on what is required to have an IND approved by the Food and Drug Administration (FDA). It also addresses topics such as requirements for preclinical safety testing, clinical trials protocol design, and data collection.

The regulation begins by defining the meaning of investigational new drugs and explains how these drugs differ from other types of pharmaceutical products. It then outlines the requirements for initiation and oversight of clinical trials, including protocols for filing a Form 1571 with FDA prior to commencing any trial. 21 CFR 312 also requires sponsors to submit detailed information about their proposed clinical trials, including a description of study objectives, expected endpoints, investigator qualifications and selection criteria, as well as a description of any potential risks associated with participation in the study. Additionally, sponsors must provide evidence that the proposed protocol has been reviewed and approved by an Institutional Review Board (IRB) prior to submitting it to FDA.

21 CFR 312 further addresses essential documentation that must be included in any submission to FDA requesting approval for an IND. This includes an investigator's brochure containing information regarding safety data collected during previous studies conducted using similar compounds or agents; reports summarizing preclinical studies performed such as toxicity testing; as well as all reports prepared by investigators involved in conducting the clinical trial. The regulation also sets forth requirements regarding monitoring ongoing clinical trials and reporting any adverse events or serious unexpected events that occur during the course of a trial.

21 CFR 312 plays a critical role in providing drug manufacturers and sponsors with necessary guidance on how to develop safe drugs while adhering to important ethical considerations related to human research protection standards. As such, it serves an essential function in ensuring that new drugs are developed safely before they can be released into the market for public use.

Who Does 21 CFR 312 Affect?

21 CFR 312 affects a wide range of individuals, including physicians, researchers, sponsors, and institutional review boards (IRBs). All of these individuals must comply with 21 CFR 312 in order to ensure that the clinical trials they are conducting are conducted in a safe and ethical manner.

How Can I Stay Up to Date With 21 CFR 312?

Staying up to date with 21 CFR 312 is essential for those conducting clinical trials. The best way to stay up to date is to regularly review the 21 CFR 312 regulations and requirements, as well as any changes or updates that have been made. Additionally, you should regularly consult with an expert on 21 CFR 312 to ensure that you are following the regulations correctly and to answer any questions or concerns you may have.

21 CFR 312 is a subchapter of the Code of Federal Regulations (CFR) that establishes the requirements for human drug clinical trials in the United States. It covers the regulations for drug safety and efficacy studies, which can include both non-clinical and clinical trials. The regulations are designed to protect human subjects while ensuring the accuracy, integrity, and reliability of data used to support applications seeking approval from the Food and Drug Administration (FDA). The scope of 21 CFR 312 encompasses all phases of drug development, including pre-clinical research, clinical trials, post-marketing studies, adverse event reporting, and manufacturing.

Under this regulation, sponsors must submit an Investigational New Drug (IND) application to FDA before beginning any human drug trial in order to obtain permission to use an unapproved investigational drug or biologic product in a clinical trial. Sponsors must provide detailed information on the manufacturing process, composition, pharmacology/toxicology data from animal models, chemistry data from nonclinical laboratory tests, previous clinical experience with similar drugs or biologics products as well as an assessment of potential risks associated with use of the investigational product.

21 CFR 312 also requires sponsors to develop comprehensive protocols for each study or trial conducted under its jurisdiction. These protocols must specify objectives for each study and define what measurements need to be taken during each stage in order to ensure that appropriate safety measures are taken throughout the entire process. Additionally, protocols should be clearly written so that consistent results are obtained across multiple sites conducting trials with similar investigational products.

Finally 21 CFR 312 ensures that adequate provisions exist for informed consent forms given to participants in clinical trials so they understand their rights as subjects and any potential risks associated with participating in a particular study or trial.

Study Guide for 21 CFR 312

1. Overview: 21 CFR 312 is a part of Title 21 of the Code of Federal Regulations (CFR). It details the regulations, procedures, and requirements that must be met in order to conduct clinical investigations involving drugs and medical devices. These regulations are designed to ensure patient safety and protection during such testing.

2. Investigational New Drug Application (IND): Subpart A outlines an application process for any new drug intended for use in a clinical investigation. The IND must include information about the preclinical pharmacology, toxicology, and other activities related to the development of the drug as well as proposed protocols for clinical testing.

3. Investigator Responsibilities: Subpart B outlines the responsibilities of investigators conducting clinical trials with investigational drugs or devices. This includes obtaining informed consent from subjects, submitting reports on progress and adverse effects experienced by subjects, maintaining accurate records, and reporting any unanticipated problems or serious adverse events that occur during a trial.

4. Sponsor Responsibilities: Subpart C outlines the responsibilities of sponsors who are responsible for conducting or sponsoring clinical trials with investigational drugs or devices. This includes monitoring study sites to ensure compliance with good clinical practice standards and providing investigators with necessary safety information regarding any investigational products they may be using in their trials.

5. Institutional Review Boards (IRBs): Subpart D outlines guidelines for IRBs which are responsible for ensuring that all research involving human subjects is conducted ethically and according to FDA regulations. This includes reviewing protocols for clinical trials before they can begin and providing ongoing oversight throughout the course of a study so that patient rights are protected throughout the duration of a trial.

6. Termination or Suspension: Subpart E outlines provisions allowing FDA to terminate or suspend ongoing investigations if any safety concerns arise during a trial that could threaten subject safety or render data generated from a trial unreliable or invalid due to protocol violations or unethical practices by investigators or sponsors involved in an experiment

What is 21 CFR 312?

21 CFR 312 is a set of regulations issued by the US Food and Drug Administration (FDA) to establish good clinical practice (GCP) standards for conducting clinical trials. It covers the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical investigations conducted under FDA regulations.

What types of studies does 21 CFR 312 cover?

21 CFR 312 covers interventional studies that involve human participants or data from human participants used to determine the safety or effectiveness of a drug product. These studies may include phase I through IV clinical trials for new drug products as well as bioavailability/bioequivalence studies and post-marketing surveillance activities.

Who must comply with 21 CFR 312?

All sponsors and investigators who are involved in conducting clinical investigations subject to FDA jurisdiction must comply with 21 CFR 312. This includes all sponsors and investigators who submit an Investigational New Drug application (IND) to the FDA or an Abbreviated New Drug Application (ANDA).

What are the key requirements of 21 CFR 312?

The key requirements outlined in 21 CFR 312 include obtaining informed consent from study participants; providing accurate records; establishing quality assurance procedures; protecting the rights and welfare of study subjects; ensuring appropriate data collection and analyses techniques; evaluating data integrity; maintaining confidentiality of subjects and their information; training personnel involved in the trial on GCP protocols; preparing detailed reports of findings; establishing audit trails; gaining approval from an Institutional Review Board before beginning any trial activity and many more important elements.

How does 21 CFR 312 affect research ethics?

By complying with 21 CFR 312, researchers ensure that human subjects are treated ethically during clinical trials. Key ethical considerations that must be met include obtaining informed consent from study participants; protecting patient privacy; minimizing risk to patients participating in trials and ensuring proper oversight throughout the duration of the trial.

What is a sponsor's responsibility when conducting a clinical investigation covered under 21 CFR 312?

A sponsor’s responsibility under 21 CFR 312 includes developing adequate protocols for each investigation, selecting qualified investigators to ensure effective oversight, obtaining informed consent forms from all patients involved in any investigational activities, providing adequate safeguards regarding patient confidentiality, informing participants about potential risks associated with any investigational activities they may be engaged in and ensuring compliance with all applicable laws related to GCP related activities.

What role does an Institutional Review Board play when conducting a clinical investigation covered under 21CFR312?

An Institutional Review Board (IRB) has a critical role when conducting investigations subject to FDA jurisdiction as outlined in21CFR312. An IRB is responsible for reviewing protocols submitted by sponsors prior to commencing any investigational activity involving human subjects. The IRB also provides ongoing review and monitoring throughout the course of an investigation to ensure continued adherence to all applicable FDA regulations related to GCP standards outlined in 21CFR312.

What type of documentation must be maintained according to 21CFR312?

According to 21CFR312 sponsors must maintain documentation outlining the duties performed by each individual involved in any investigational activity related tot he trial including protocol development activities, informed consent process details etc.. In addition sponsors must keep thorough records detailing all data collected during each stage off the trial as well as facilitate audit trails so that investigators can easily trace back any changes made during analysis or reporting stages off thee trial process..

How often should audits take place according for 21CFR312 ?

Sponsors must perform audits at least annually according twenty one C F R three twelve The objective off these audits is two ensure compliance within applicable regulatory standards In some cases additional audits may be necessary depending on complexity off thee protocol being investigated or if unusual deviations occur during thee course off thee trial ..

When should sponsors provide reports to FDA based on their findings ?

Sponsors should provide reports too FDA based on their findings no later than thirty days after completion off thee investigation . If necessary , requesting additional time due two extenuating circumstances can bee performed before submitting report results .

Review Questions for 21 CFR 312

MCQ 1: What is the purpose of 21 CFR 312?

A. To establish rules and regulations for the production and sale of drugs

B. To protect public health by ensuring drug safety

C. To reduce the cost of pharmaceuticals

D. To create standards for food safety

Answer: B. To protect public health by ensuring drug safety. 21 CFR 312 is a section of federal regulations that are designed to ensure drug safety through the establishment of rules and regulations for their production, distribution, labeling, quality control and advertising. The primary goal of this regulation is to protect public health by guaranteeing that all pharmaceutical products meet minimum standards for efficacy, potency, purity and quality.

MCQ 2: What type of information must be included on a label in accordance with 21 CFR 312?

A.Ingredient list

B.Expiration date

C.Instructions for use

D.Nutritional value

Answer: A. Ingredient list. According to 21 CFR 312, all pharmaceutical labels must include an ingredient list containing information about all active ingredients used in the product as well as any inactive ingredients that make up more than 2% of the total weight or volume of the product. Additionally, labels must also include information about any colorants used as well as impurities present in trace amounts that could adversely affect users if consumed in large quantities over time.

MCQ 3: How often must pharmaceutical companies submit manufacturing records to the FDA?

A. Monthly

B. Annually

C. Quarterly

D. Biannually

Answer: C Quarterly. Pharmaceutical companies must submit detailed manufacturing records to the Food and Drug Administration (FDA) on a quarterly basis when filing reports required by 21 CFR 312, Subpart G-Requirements for Registration of Manufacturers/Processors/Packers/Holders (§312). This includes comprehensive records regarding quality control systems testing procedures, manufacturing facilities, operations specifications, equipment maintenance schedules and more that demonstrate compliance with FDA regulations for safe production practices and product quality assurance purposes

MCQ 4: What role does advertising play within 21 CFR 312?

A .It is permitted but heavily restricted

B .It is not mentioned at all

C .It is prohibited altogether

D .It is unrestricted

Answer : A It is permitted but heavily restricted. The advertising and promotion requirements outlined in 21 CFR 312 provide comprehensive guidance on how firms should market their products while remaining compliant with regulatory requirements set forth by the Food & Drug Administration (FDA). While these regulations do permit firms to advertise their products under certain conditions it also places several restrictions such as prohibiting false or misleading claims or engaging in deceptive practices when promoting their products

MCQ 5 : Which type of information can be shared between manufacturers when trading biological materials according to §312.50(a)(1)?

A .Confidential trade secrets

B .Patent information

C .Test results

D .Facility locations

Answer : C Test results. Section 312.50(a)(1) outlines which types of information can be shared between manufacturers when trading biological materials such as microorganisms or raw materials intended for use in animal feed or fertilizer applications, medicinal drugs or food additives etc.. Test results from safety analysis performed on such materials may be shared between manufacturers provided they have been adequately validated for accuracy prior to disclosure

MCQ 6: Which factors are taken into account when determining whether a clinical trial should be conducted?

A. The predicted risk or benefit associated with a drug's use

B. The number of participants needed in a study to obtain valid results

C. The cost associated with conducting the trial

D. All of the above

Answer: D. All of the above. 21 CFR 312 states that clinical trials must be conducted in order to determine whether a drug is safe and effective and that considerations such as potential risks, benefits, number of participants needed for valid results, and cost must all be taken into account when making this determination.

MCQ 7: When must an investigational new drug application (IND) be submitted according to 21 CFR 312?

A. When initiating any clinical investigations involving a new drug

B. When submitting new marketing applications for a drug product

C .When introducing any changes to an approved drug product

D .All of the above

Answer: A .When initiating any clinical investigations involving a new drug . According to 21 CFR 312, an IND must be submitted prior to initiating any studies or trials involving an investigational new drug or biologic agent in humans in order to ensure patient safety and health protection standards are met prior to initiation of these activities.

MCQ 8: What type of data is required when submitting an investigational new drug application (IND)? A . Clinical data from past trials involving similar products

B .Data on animal testing conducted using the proposed product

C .Data on manufacturing processes used during development

D .All of the above

Answer: D .All of the above . In order for an IND to be approved by FDA regulatory authorities all available information regarding preclinical studies, pharmacology/toxicology studies, chemistry manufacturing controls, previous clinical experience with similar products, proposed protocol(s), investigator qualifications must all be submitted alongside supporting documents outlining these details so that decisions can be made based on available data points provided in these documents.

MCQ 9: What type of review process takes place after submission of an investigational new drug application (IND)?

A . Statistical analysis using collected clinical data

B .A comprehensive evaluation by FDA regulatory experts

C .Approval from Institutional Review Board (IRB)

D .All of the above

Answer: D .All After submission of an IND both statistical analysis using collected clinical data as well as comprehensive evaluations by FDA regulatory experts take place in order for decisions about approval or rejection to be made; additionally Institutional Review Boards review all materials before approving studies or trials for conduct with human participants per FDA guidelines outlined in 21 CFR 312

CCRPS offers certification with 21 CFR 312 review in depth. Demo our courses today to learn more.

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todays-xkcd · 4 months ago

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Hint: If you ever encounter this puzzle in a crossword app, just [term for someone with a competitive and high-achieving personality].

A Crossword Puzzle [Explained]

Transcript

[A square 15x15 crossword puzzle is shown. Only 21 of the 225 squares are black. The black squares are in a pattern that are 180 degree rotationally symmetrical. Three black squares down from the 11th column and similarly three black squares up from the 5th column. Three black squares out from the right in row 7 and then two more black squares diagonally up from the end. Similarly three black squares out from the left in row 9 with two more black squares diagonally down from the end. A single black square is three above the first black square on the diagonal going down to the right and similarly there is a black square three under the first of the diagonal squares going down to the left. (Row 6 column 12 and Row 10 column 4). Finally there are three black squares on a diagonal crossing over the central point by going up from the left through the central point (Row 8 column 8). There are numbers at the top of every column (except the one that is a black square) and similarly at the left edge of all rows (except the one that is a black square). There are also numbers at the bottom of every black segment (except the one that reaches the bottom) and all rows after black segments except the one that reaches the right edge. In total all numbers from 1 to 51 is written. They are written in reading order from 1 to 51.]

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51

[Below the square there are two rows of clues for each number that belongs to across (rows) and to the right there are one row of clues for each number that belongs to down (columns). Both segments have an underlined and bold title above the clues. ]

'''Across'''

1. Famous Pvt. Wilhelm quote

11. IPv6 address record

15. "CIPHERTEXT" decrypted with Vigenère key "CIPHERTEXT"

16. 8mm diameter battery

17. "Warthog" attack aircraft

18. Every third letter in the word for "inability to visualize"

19. An acrostic hidden on the first page of the dictionary

21. Default paper size in Europe

22. First four unary strings

23. Lysine codon

24. 40 CFR Part 63 subpart concerning asphalt pollution

25. Top bond credit rating

26. Audi coupe

27. A pair of small remote batteries, when inserted

29. Unofficial Howard Dean slogan

32. A 4.0 report card

33. The "Harlem Globetrotters of baseball" (vowels only)

34. 2018 Kiefer song

35. Top Minor League tier

36. Reply elicited by a dentist

38. ANAA's airport

41. Macaulay Culkin's review of aftershave

43. Marketing agency trade grp.

44. Soaring climax of Linda Eder's ''Man of La Mancha''

46. Military flight community org.

47. Iconic line from ''Tarzan''

48. Every other letter of Jimmy Wales's birth state

49. Warthog's postscript after "They call me ''mister'' pig!"

50. Message to Elsa in ''Frozen 2''

51. Lola, when betting it all on Black 20 in ''Run Lola Run''

“Down

1. Game featuring "a reckless disregard for gravity"

2. 101010101010101010101010 [sub]2→16

3. Google phone released July '22

4. It's five times better than that ''other'' steak sauce

5. ToHex(43690)

6. Freddie Mercury lyric from ''Under Pressure''

7. Full-size Audi luxury sedan

8. Fast path through a multiple choice marketing survey

9. 12356631 in base 26

10. Viral Jimmy Barnes chorus

11. Ruby Rhod catchphrase

12. badbeef + 9efcebbb

13. In Wet Let's ''Ur Mum'', what the singer has been practicing

14. Refrain from Nora Reed bot

20. Mario button presses to ascend Minas Tirith's walls

24. Vermont historic route north from Bennington

26. High-budget video game

28. Unorthodox Tic-Tac-Toe win

29. String whose SHA-256 hash ends "...689510285e212385"

30. Arnold's remark to the Predator

31. The vowels in the fire salamander's binomial name

32. Janet Leigh ''Psycho'' line

34. Seven 440Hz pulses

37. Audi luxury sports sedan

38. A half-dozen eggs with reasonably firm yolks

39. 2-2-2-2-2-2 on a multitap phone keypad

40. .- .- .- .- .- .-

42. Rating for China's best tourist attractions

43. Standard drumstick size

45. "The rain/in Spain/falls main-/ly on the plain" rhyme scheme

#xkcd #xkcd 2957 #webcomics #a crossword puzzle

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onderkaracay · 6 months ago

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🎯 FENERBAHÇE'Yİ KULLANARAK ALGI DEĞİŞTİRMEYE KALKAN DENSİZLİĞE İNSANLIK AHLAKINI YAŞATAN BİR TÜRK'ÜN YANITLARI 🎯

Bu yazı ile bugün yeryüzü yerinden oynayacak üzerinde insan olarak yaşayanlar silkinip kendine gelecek.

ilmi sır gereğidir. Görülen lüzum üzerine yaşattıklarını sırayla yaşatan ahlakın ihtiyaç duyulan yeni tokat yanıtlarını okuyacaksınız.

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Mobbing Bank insanlık tarihinin bir mahkemesi ve duruşmalarını insanlığın önünde gören insanlığı yaşatacak töre devrimini gök tanrının gazabı ile yeryüzüne getiren hak ve adaleti zulme mahşer tufanını susuz şer denizinde yaşatarak birinin canının alınmasını bu sahneye taşıtan ve geriye kalanları canlı ölülere çeviren yüksek insanlık ahlakının kaleminden dökülerek tarihin kalemi tarafından yazılmış kitap kılığında bir geminin şerrin holdinginin amiral gemisi olarak bilinen bankasının itibarını o şer denizinde kurulduğu gün batıran ve geminin kaptanı bir Türk dünyaya bedeldir iki Türk lak lak alay geçmesinin hesabını kozmik bilgiler ile şifresini çözerek hesabını soran o geminin kaptanı görünmez Türk'ün gizli eli ve adaletidir.

Bilenler bilir ilk duruşmalar bu sosyal ağlar denen şer denizinde geminin 15 Aralık 2015 tarihinde en uzun gecede en uzun kabusu yaşatmak için şer, fitne ve fesadı yönetmeye kalktıkları şer denizine mahşeri yaşatmak için inmiştir.

21 Ocak 2016 tarihinde ülkenin en zengin iş adamı kendi hastanesine yetiştirilemedi diye yaygara kopararak bu ibretin bir parçası oldukları algısını gizlemeye kalkarak işbirliğinin canının bu ibret adına hak tarafından alındığına şahit olmuş bunu insanlığa deşifre etmiş ve geriye kalan dünyada ki kendini tanrı yerine koyarak tepeden insanlığa bakan tüm zalimlerin en aşağıya düşürdüklerini sandıkları o tarihin koca yürekli Türk'ünün aracı olduğu gazaba uğrattılarak kalpleri karartılmış (Her leke çıkar kalp karası lekesi çıkmaz. Bu ibretin efsane olacak sözüdür.) bir şekilde canlı ölülere dönüşüklerine şahit olmuş şer denizine tek bir seferde düzenlediği görevini dört büyük tarihe mal Türk komutanların huzurunda görevi tamamlayarak devrimi Anadolu'da başlatmak için geri dönmüştür.

Türk insanlığının atam Nuh'un yaşattığı tufan benzeri bir tufanı bu sefer su harcamadan susuz denizde gerçekleştirerek Anadolu'ya geri döndüğü gibi insanlık ile yeryüzüne ilk atam Hun gibi geri dönmüştür.

Şimdi o tokatı yeryüzünde nasıl arttığının ibretlik yanıtlara gelelim.

Fenerbahçe ile fanatizmi küresel abilerinin talebi ile algı değiştirmek istediklerini yazdım.

Bunu kalktı kendisi ispat etti. Nasıl mı?

Şöyle söyleyerek;

Mustafa Kemal Atatürk'ün hangi takımdan olduğunda daha önemlisi hangi takımın Mustafa Kemal Atatürk'ün peşinden gidiyor o daha değerlidir benzeri bir ifade ile algı değiştirmeye kalktı.

Sanki bu işbirlikçi Fenerbahçe başkanı olana kadar Fenerbahçe Mustafa Kemal Atatürk düşmanı bir çizgide olduğunu kendisi geldikten sonra bu çizgiye geldiğini ima ederek oradan fanatizm akılsızlığını kendi lehine çevirmeye kalktı.

Sonuç ortada. Başarı yok. Git o zaman tefecilik yap. İngiliz ve Amerikan derin devletine çalış ne işin var Fenerbahçe'nin başında senin. Paradan anlarsın sen spordan ne anlarsın? Fenerbahçe para diyorsan haklısın kendine yakışanı yapıyorsun.

Yeryüzüne Türk töresinin adaletini getiren o Türk'ü hiçe saymaya kalktı.

Hiç olmak nedir? Onu da bilmez bu gaflet holdingin sahipleri.

Amerikan derin devlet yapısı CFR uzantısı Bilderberg terör örgütünün bir üyesi olduklarını gizleyerek. Bu gizli yapılan toplantılara Mustafa Koç katılması gereken gazeteci, her siyasi partiye yerleştirdikleri siyasetçiler ve kullandıkları iş adamlarını götürür emir verir kendi çıkarları adına kullanırlardı. Hala Ömer Koç pişmanlık duymadan bu görevi sürdürüyor. Türk'ün insanlık davası duruşmaları açık seçik bir şekilde bu gizli örgütün aksine sizlerin gözlerinizin önünde sürüyor.

Atatürk sonrası bir umut olarak Karaoğlan ile anılan Bülent Ecevit bile tuzağa düşerek bu gizli toplantılara katılmıştır.

2009 yılında Sabancı Holding'in amiral gemisi bankasının yönetim kurulu başkanı iken Osmanlı imparatorluğuna Serv anlaşmasını dayatan İngiliz derin devlet yapısı olan Chatham House ülkemiz aleyhine ajanlık yapmak adına mütevelli heyetinde yer alan Suzan Sabancı Dinçer tarafımca yüksek bir ses ile deşifre edilince istifa etmek zorunda kaldı.

Yürek yemiş gaflet holdingin fanatizmi kullanarak algı değiştirme rolünü üstlenen ve Antalya'da G-20 toplantısında konuşma yaparak ülkemizde ve dünyada asıl sorunun kapitalizm olduğunu söyleyerek günah çıkarmaya kalkan bu densizlik İngiliz derin devlet yapısının kurulsal ortağı olarak Ali Koç bu görevi gururla yapacağını o tarihten sonra üstlendi.

Küresel şer böyledir. Kullanır kimsenin sonunu düşünmez düşünmesine izin vermez. Türk bunun hiçbirine izin vermez.

Antalya'da yapılan G-20'ki konuşmasında sorun kapitalizm günah çıkarma girişimi sonrasında bir soru sordum bir tek ben sordum zaten.

Dedim ki;

Ülkede sorun kapitalizm ise sorun kapitalistler kim?

Hala yanıt bekliyorum.

Bu sorunun yanıtını almadan bu Türk yeryüzünden gitmeyecek. İlmi sır böyle bir görev verdi.

Türk görevi yaşamdan alır aldığı görevin gücünü huzurlu yaşamın ve insanlığın yararına kullanır.

Oğuz Kağan adaleti böyledir.

Oğuz Kağan adaletinin Anadolu anıtı Mustafa Kemal Atatürk ile insan kandırmaya kalmanın bedeli işte budur.

Zulmü insanlık adına bir ibret ile bitir demektir Türk.

Çünkü Türk insanlığın yeryüzünde ki zulme karşı adaleti, hakkın kamçısı ve zalimliği hizaya getirme gücüdür.

Sizde zerre kadar yüz ve ahlak olmuş olsaydı dedenizin Kenan Evren denen diktatöre yazdığı mektubu ortaya çıkardığımız gün bu ülkeyi terk edip giderdiniz.

Bir gün Ali Koç kendi eserleri değilmiş gibi bu ülkede çocuklarımın geleceğinden endişe ediyorum dedi.

Buna yanıt veriyorum?

Tefeci bankalarınız ile yaklaşık iki yüz bin bankacıya yirmi yıldır mobbing uygulayarak zulüm ettiğiniz çoğunu issiz bıraktınız çocukları babasız kalan arkadaşlarım var biri sizin bankanız Yapı Kredi Bankası tarafından haksız yere işten çıkarıldı kalp krizi sonucu hayatını kaybetti. Bu çocuklar çocuk değil mi?

Sebepsiz işten çıkardınız Önder Karaçay'ın çocukları çocuk değil mi?

Yıllarca mahkemelerde hak arayışı sürdürdüm oralara müdahale ederek asrın davasını Türk Fırtınası kitabımın iddia ettiği gibi insanlık önünde görülen bir davaya dönüşmesine sebep oldunuz.

Ne diyordu ilmi sır ile ibret yaşattığınızı yaşamadan ölmeyecek canlı ölülerrsiniz diyordu değil mi?

Türk insanlık adaletinin mahkemesi içinde adalet olmayan adalet saraylarında değil hak mahkemesinin bir ibret ile yeryüzünde duruşmaları herkesin huzurunda yapılan bir adalettir.

Nasıl bittiğinizi anladınız mı şimdi. Her mahallede bir milyoner beslemesi her darbe ve krizde bir vurgun ile hak yutan azgınlık bittiğinizi şimdi anladınız mı?

İntihar etmek isteseniz bile edemezsiniz. İbret çünkü daha bitmedi. Uzun ömürlü bir zulüm olarak türediniz çünkü.

Atatürk ile toplumu aldatmaya hiç utanmıyor musunuz?

Bir Türk bir gün bunu yaparsa ne yaparız diye hiç düşünmediniz mi?

Tüpraş'ı İngilizlere kaptırırken oraya ortak olarak Türk ulusunu İngilizler adına bu ortaklık ile çalıştığınızı nasıl gizlemeyi planladınız?

Migros Tüpraş İngilizlere geçsin diye mi satıldı?

Hem Tüpraşa ortak olacaksınız hemde opet ortaklığı ile enerjide tekel olacaksınız. Biz Türkler buna izin verir miyiz?

Kamulaştırma kararları alındığında göreceksiniz. Türk devleti aklı neredeymiş ya da kimdeymiş?

Medya algısı ile din ticareti ve para gücü ticareti ile toplumu aldatıp kendi çıkarına iş yapanları reklam parası ile iş başına getirmenin demokrasi olmadığını göreceksiniz.

Hazmede hazmede yaşayacaksınız yaşattığınız zulmü.

Din ticareti ideolojisi ve para gücü ideolojisi ortaklığı tarih olmaktadır.

Türk Fırtınası kitabı ne demişti kapitalizm Anadolu'da yıkılmaya başlayacak.

Türk insanlık ahlak ve hukuku ile çaldıklarınızı para olarak elinize tutuşturup sizi kamulaştırma yaparak ödüllendireceğiz. Neticede para sizin tanrınız. Ona kavuşacak yalnız daha fazla büyümesi için Anadolu topraklarını ve Türk ulusunu buna alet ederek para çoklama zulmüne devam edemeyeceksiniz.

Yinede bir bakkal olarak yola çıkıp ülkede bakkal bırakmayarak bitme noktasına gelmeyi büyük bir başarı olarak zulüm tarihine yazdırdınız.

En büyük hatanız ibretin bir parçası olarak sen kimsin issiz birini mi muhatap alacağız şeklinde iblise benzer büyüklenmeye kalkan halinizdi. Bunun telefon kayıtları o banka ile haklarımı neden eksik ödediniz dediğim gün biz büyük bir bankayız haklarının bir kısmını ödememe kararı aldık ne yapmak istiyorsan yap dediğiniz gün hak mahkemesi duruşmalarını farkında olmadan başlattınız.

Karşınızda Oğuz Kağan adaleti olduğunu nereden bileceksiniz. Hem ülkenin en büyük holdingleri olarak buyiklenmek varken.

Yaşamda nefesine yenilerek şeytana dönüşen insan dışında kimse büyüklenmez. İnsan niyetini nefsine satabilen kılık değiştirmiş bir şeytan olabilir. Şeytan diye başka bir canlı yoktur.

İnsanlığın zıttı negatif enerjinin yaşattığı bir yaratıktır şeytan veya şeytanlık. Batı sömürgesi ve onun uşaklığını yapan herkes bunu çok iyi bilir.

MaltaSA vatandaşlığı almak zorunda kalan Sabancılar kadar olamadınız. Paralarını offhore bankacılık yapmak için yurt dışında tutarak batıya ne kadar bağlı ve bağımlı olduklarını ispat ediyorlar. Siz kendinizi onlardan daha güçlü bir holding olarak algı yolu ile satabileceğinize inandınız değil mi?

Bakın Sabancı holding Yönetim kurulu başkanı adını hatırlayamadım isteyen bulur bir sözünde İngiliz hayranlığını nasıl ifade ediyor;

İngiltere'de bir kelebek uçmaya kalksa Filipinler'de fırtına çıkar.

Bir Türk buna şöyle yanıt verdi;

Mobbing Bank kitabının gerçek adı 'TÜRK FIRTINASI' olup kitabın kapağında şifrelidir. Zulüm ile insanlık mücadelesi savaşının Mobbing Bank ismi ile zulüm insanlık adaleti ismi ile Türk Fırtınası şifrelenmiştir.

SkandALBANK ile amiral gemisi o banka bu şekilde ara bir ad ile yazılmıştır.

Şu anlama gelir bir Türk yeryüzünde insanlık adına adalet için sahneye çıkarsa bütün dünyada fırtına çıkar. Aynı Oğuz Kağan atam ve onun son onuru Mustafa Kemal Atatürk atam gibi.

Önder Karaçay bu büyük insanların insanlık adına yaptıklarını yaşanan zulme son vermek için BEKLENTİZLİK MAKAMINDA önderlik yapmaya geldi.

İnsanlık tarihinin o büyük ilmi sır ile yaşattığı tokat yanıtın adıdır Türk Fırtınası

Bundan sonra kitabım Türk Fırtınası diyor ki diye yazacağım.

Aşama değiştiriyoruz.

Şerri çil yavrusu gibi bütün dünyada darmadağın etmek için.

Türk korkususuzluğun adıdır.

Bütün bunları nasıl yapıyorsun diye soruyorlar?

Anlamak için bile tam ve ham Türk olmak gerekir diyorum.

Bu ne demek diyorlar?

O zaman Türk'ün yaptıklarını yapabileceklerini seyret sahneye çıktı gör diyorum. Eğer şeytan gözünü bağlanmamış elini kolunu bağlar gibi tefecilik ile seni esir almamış ise anlarsın.

Yoksa canlı ölüsün.

Bu şerre hizmet eden ve vazgeçmeyen, insan gibi davranarak bunlara fırsat vermeden akıl dolu yönetenleri kullanarak isyan etmeyen herkes canlı ölüdür.

Mustafa Yıldırım'ın yazdığı Sivil Örümceğin Ağında adlı kitaptan öğrenerek bunun üzerine gittim ve bütün pis ilişkilerini ortaya cesaret ile ortaya çıkarttım.

Cumhuriyet bitmiştir diyen ve Cumhurbaşkanı bile yapılan İngiliz ajan yetiştirme adına faaliyet gösteren Exeter üniversitesi mezunu birisine bile Suzan Sabancı Dinçer İngiliz kraliyet ödülü verilmesini sağladı. Hadi koçum göreyim seni diye.

Bugün aynı yeri Ankara ve İstanbul büyükşehir belediye başkanlığını kazanan ve medya ile Cumhurbaşkanı adayı olsunlar diye pohpohlanan oraya hangi gaflet holdingin kurumsal işbirliği gereği giden ve Türk ulusu yerine yerel halk sözünü söyleyecek kadar aşağılık bir seviyeye kendilerini düşüren toplumu yine Atatürk ile kandırmaya kalkan siyasi kişilikleri de geri adım atmaya davet ediyoruz.

Aksi takdirde bedeli çok ağır olacaktır.

Bu anlamda Cumhuriyet Halk Partisini bir kez daha uyarıyorum.

Mevcut zihniyetin yeniden toparlanmasını sağlama aparatı değilseniz çıkın Mustafa Kemal Atatürk'ün yaptığı ve yarım kalan devrimleri Türk Fırtınası ile yeryüzüne geri dönen Türk töre adaletinin devrimlerini yapacağız diye Türk ulusunun karşısına çıkın.

Çıkamıyor iseniz bu düzenin hizmet partisi olduğunuzu ispat etmiş ve Cumhuriyeti yıkmaya kalkanlara kalkan olan bir parti olarak tarih olacaksınız.

Töre aracısız ve partisiz ideolojisiz Türk ulusu iradesinin üzerinden irade olmadığının devrimini yapmak adına mahşer tufanı efsanesinin komutanın emri yerine getirilmek için canlı ölüler ibreti yaşatılarak bu ibrete farkında olarak ya da olmadan tuzağa düşen herkesin tarihin çöplüğüne göndermek için gelmiştir.

Türk yeryüzünde şeytanlığı nefessiz bırakan iradenin adıdır. Herkes ona göre safını seçsin.

Önder Karaçay

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