#GoodManufacturingPractice

[biotichealthcare]

How to Control the Quality Parameters in Pharmaceutical Manufacturing? - The Quality of Medicines has always remained a major concern in the pharmaceutical industry. It is because of the uppermost safety of drugs that pharma companies aim to attain. Quality Assurance is a far-ranging concept covering all matters altogether that influence the quality of medicines. In the pharmaceutical industry, companies have been continuously manufacturing and supplying new and better medicines by taking care of the global quality standards. There are necessary Quality Parameters in Pharmaceutical Manufacturing that require to be controlled in an appropriate manner. In this blog, we have mentioned all the quality parameters executed in the manufacturing of pharma products.

[amitshridhar]

Current good manufacturing practices (cGMP), Good manufacturing practice (GMP) - Wikipedia

19/03/2024, tuesday 19 march 2024, 11:24 a.m, indore, madhya pradesh, india.

[roadmaperp-software]

Good Manufacturing Practice(GMP)

GMP is a critical component of quality assurance in the manufacturing of pharmaceuticals, food and beverage products, cosmetics, and medical devices. Overall, GMP is an essential component of ensuring the safety, quality, and efficacy of products in the pharmaceutical, food, and medical device industries. Compliance with GMP guidelines helps to ensure that products are consistently manufactured to meet the highest quality standards, which is essential for protecting the health and well-being of consumers.

[corpbiz-advisor]

Learn the step-by-step process of GMP certificate registration in India and discover its key benefits, including regulatory compliance and improved product quality.

[thxnews]

Cell BioEngines, Miltenyi Forge HSCT Manufacturing Deal

Innovating Blood Cancer Treatment

Cell BioEngines, Inc., a trailblazer in stem cell and immune cell therapies for blood and solid cancers, has announced a strategic partnership with Miltenyi Bioindustry. This collaboration aims to develop and manufacture an expanded hematopoietic stem cell transplantation (HSCT) product, marking a significant advancement in hematology-oncology clinical applications.   Revolutionizing Bone Marrow Transplantation Cell BioEngines is set to transform blood cancer treatment with its proprietary stem cell expansion technology. This 'off-the-shelf' curative approach for bone marrow transplant patients uses a patented small molecule to enhance the number of hematopoietic stem cells from umbilical cord blood, addressing the critical issue of donor availability for allogenic HSCT.  

Miltenyi's Expertise in GMP Manufacturing

Streamlining Clinical Trial Preparations Under the agreement, Miltenyi will initiate development leading to Good Manufacturing Practices (GMP) manufacturing of Phase 1 clinical trial batches for Cell BioEngines' CBE-101 clinical program. Dr. Ajay Vishwakarma, CEO of Cell BioEngines, emphasized the benefits of this partnership, allowing the company to focus on developing safer, more effective stem cell cancer treatments.   Integrating Cutting-Edge Platforms for HSC Therapies Miltenyi brings to the table its proprietary platforms for cell processing and analysis, crucial for HSC therapies. Leonard Pulig, President of Miltenyi Biotec, highlights the CliniMACS Prodigy® platform's role in optimizing HSC isolation and expansion. This collaboration also involves integrating the platform with bioreactors for large-scale manufacturing, demonstrating Miltenyi's prowess in cell therapy process development and product scale-up.  

Financial Terms and Future Prospects

Although the partners have not disclosed the financial details of the agreement, the Cell BioEngines and Miltenyi collaboration is set to achieve significant advancements in the field of hematopoietic cell therapy.   About Cell BioEngines Cell BioEngines, Inc. actively pursues the revolution of cancer treatment, developing allogenic cell therapies conceptualized as 'drugs,' aiming ambitiously to turn all cancers into curable diseases. Furthermore, their pioneering Stem-SPACE™ platform technology plays a crucial role in this endeavor. Importantly, it facilitates the production of clinical-grade cells on a large scale. Additionally, this innovative approach enables Cell BioEngines to explore a diverse array of cell and gene therapy product candidates. Each of these candidates holds significant promise, not just in clinical effectiveness but also in commercial viability. Moreover, the company's focus extends beyond mere treatment to potentially curing various forms of cancer. This goal is rooted in their cutting-edge research and development efforts. Furthermore, the versatility of the Stem-SPACE™ platform positions Cell BioEngines at the forefront of the biotech industry. Significantly, it allows for rapid adaptation and response to emerging therapeutic needs and challenges in oncology. Consequently, this positions Cell BioEngines as a key player in the future of cancer treatment, potentially transforming the landscape of medical care for cancer patients worldwide.   About Miltenyi Biotec Miltenyi Biotec, renowned as a global leader in biomedical research and cellular therapy advancement, consistently supports every stage of cell and gene therapy product development. Additionally, the company's comprehensive solutions have established industry benchmarks in manufacturing and analyzing complex cellular products. Moreover, Miltenyi's specialized division, Miltenyi Bioindustry, capitalizes on its expertise by developing and manufacturing lentiviral vectors and cell and gene therapy products. Importantly, this division employs the CliniMACS Prodigy® platform, effectively scaling from pre-clinical stages to commercial production. This strategic utilization of resources and technology underlines Miltenyi's commitment to advancing the field of cellular therapy.   Sources: THX News & Cell BioEngines, Inc. Read the full article

[pharmaconferenceandexpo]

Track 16: Good Manufacturing Practices (GMP) CALL FOR ABSTRACT:- "Your Ideas, Our Platform: Be Part of the Discussion." Join us at the 15th Digital Pharmaceutical Innovations Exhibition & Congress” from May 14-16, 2025, in San Francisco, USA, and virtually.

Submit here: https://pharmacy.utilitarianconferences.com/submit-abstract Paper Submission Deadline Is January 15, 2025

# Digital Pharmaceutical #GoodManufacturingPractices #GMP #QualityControl #FoodSafety #PharmaceuticalStandards #Compliance #SafeProduction #ManufacturingExcellence #QualityAssurance #HygieneStandards #RegulatoryCompliance #CleanProduction #ISOStandards #HealthAndSafety #IndustryStandards #GMPTraining #SafeManufacturing #QualityFirst #ProcessValidation

[cbdmlmopportunity-blog]

#10xPURE Gold Roll On supports higher levels of #CBDa for #EXTRA-STRENGTH #PainRelief! Not to mention it’s the perfect size to take with you anywhere you go! ⠀⠀ CBDa is the mother of #CBD. CBDa is raw, #pureCBD and #free of solvents, combustion and toxic residue, and when processed, especially at high heat, converts to CBD, and destroys most or all the CBDa. Think of it as harvesting fresh vegetables from your back yard and cooking them at high heat----something good is always lost. ⠀⠀ Early CBDa research suggests it could deliver potent #relief by selectively inhibiting an enzyme in our bodies called #COX-2. COX-2 is an enzyme that triggers when you experience injury. The response is #natural. CBDa #research suggests that it reduces the production of #prostaglandin by blocking the COX-2 enzyme. Less prostaglandin results in less #discomfort. ⠀⠀ The best of both worlds would be a #plant-based product/ingredient that blocks COX-2 without blocking COX-1. Research suggests that CBDa does just that. ⠀⠀ For Extra-Strength #Muscle and #Joint-Relief order yours today! ⠀⠀ All of our CBD is #organically-grown, #GMP ( #GoodManufacturingPractice ), #Lab-Tested🔬, and #non-GMO .#nonGMOCBD https://www.CBDMLMOpportunity.com

[haccp-polska]

Registration in the EU transparency platform #eu #europeancommission🇪🇺 #HACCP #haccppolska #foodsafety #lobbying #lobbyist #feedsafety #goodmanufacturingpractice #qap #qualityassurance #qualityassurancepoland (w: European Parliament) https://www.instagram.com/p/B-TzCOgnrtE/?igshid=gzopeb9depe3

[biotichealthcare]

How Quality Control Is Done in the Pharmaceutical Industry – Quality control is a must and it cannot be ignored. Ask any pharma professional about one of the most important and critical aspects of drug manufacturing? You will get the answer as quality. The quality of the drugs has always been a major concern in the entire pharma sector. The term quality control simply depicts the amalgamation of all the decisions and tasks undertaken to ensure the purity of a medicine. If you are a pharma aspirant or any interested business seekers looking to enter the pharma industry and you want to figure out How Quality Control Is Done in the Pharmaceutical Industry, then read this blog till the end.

[pharmahemp]

We are very proud to announce that PharmaHemp is officially GMP certified company for cosmetics production under a global ISO 22716:2007 standard. 📃 With successfully completed demanding and independent audits we prove to our customers, that quality control is our promise. Our GMP compliance was verified and confirmed by inspection audit one of the world’s leading certification bodies, Bureau Veritas. You can Read more about certification in our news section on pharma-hemp.com #certification #certificate #GMP #gmpcertified #certified #goodmanufacturingpractice #verified #verification #confirmed #bureauveritas #quality #pharmaceuticalstandard https://www.instagram.com/p/B70zlbGBFkw/?igshid=1uwtdnm4psbni

[montanaemuranch-blog]

Winter can be grueling, so we recommend Recco Advanced Rescue Technology! If you're ever caught in a bad situation, rescue teams can find you quickly! Read more: https://bit.ly/376sBeX “It is a great advantage to be able to live off your idea, but it is nothing compared to meeting someone who tells you they are alive because of your idea.” – Magnus Granhed, founder of RECCO AB #Montanaemuranch #Emuranch #Emufarm #Emu #Emuoil #Pureemuoil #CertifiedEmuOil #GradeAEmuOil #MadeinMontana #GrowninMontana #Goodmanufacturingpractice #Health #Wellness #Safety #Skiing #Avalance #Recco #Lostpersons #Montana #Flatheadvalley #Kalispell #KalispellMT #Cosmetics #cosmeticsafety #Natural #Naturalproducts #Wintersafety #Weatheradvisory #Wintersports   https://www.instagram.com/p/B7L_i5ahj5C/?igshid=1o0f50y0lfe49

[magicalworldofcbd-blog]

I hate when I see things like this. I've been warning so many people that NOT ALL CBD IS CREATED EQUAL. Hopefully now, you come to a real company #cbd #cbdoil #cbdoils#cbdflowers #ctfo #cbdproducts #texas #texascbd #health #highqualitycbd #cbdlife #wellness #cbdbenefits #cbdwellness #helps #natural #organics #gmp #goodmanufacturingpractice #certifiedorganic #cbdusers #buyfromme #painfree https://www.instagram.com/p/B2BAl2TH4FV/?igshid=1y4ffj9mqgzh

[food-safe]

HACCP Training

If you are in New Zealand book an introduction to HACCP in a classroom setting with our expert trainer on this link

If you are a company in New Zealand or overseas we can come to your site and deliver our highly rated training to Global Codex Alimentarius Standards just email our Director & Lead Trainer: keith@foodsafe.net.nz or call us at +64 9 2814226

Don't take our own word for it. We have the highest training feedback scores (290+ 5☆ reviews), year-on-year. View these on both Google Business & Facebook coupled with the best Company Management feedback project scores!

Some more about HACCP below:

HACCP stands for Hazard Analysis Critical Control Point

HACCP has its origins in the US space program and was further developed by the Codex Alimentarius Commission as a methodology and food safety risk management system. It is used to identify, prevent, and proactively control food safety hazards.

What are some of the basic definitions?

Hazard:

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Food safety hazard analysis:

A food safety hazard analysis is done in order to determine which potential hazards need to be controlled, how much control is needed, and which combination of control measures should be used in order to make sure that food is safe.

Supporting Programmes / Good Manufacturing Practice (GMP):

A production and testing practice that helps to ensure a quality product. Basic preventive guidelines for plant and facility operations. Guidelines aimed at food processors aim to include all HACCP methods and procedures and typically address (1) plant design and construction material, (2) water supply, (3) plumbing and toilet facilities, (4) equipment and utensils, (4) raw food handling and testing practices, (5) personal hygiene, (6) pest control, and (7) waste disposal.

Risk analysis:

A process consisting of three interconnected components: risk assessment, risk management and risk communication.

Risk assessment:

A scientifically based process consisting of four steps (i) hazard identification (ii) hazard characterisation, exposure assessment (iii) and (iv) risk characterisation.

Verification:

Act or process of establishing (confirming) the accuracy or existence of something; in the quality field, verification is a systematic, objective, and documented process of confirming that a product or service conforms to various requirements (customer, regulatory, etc.). A process that uses objective evidence to confirm that specified requirements have been met.

HACCP management systems consist of seven principles and use a logical methodology. What are these seven principles?

What are the seven principles of HACCP are:

1. Hazard Analysis

Identify any Physical (P), Chemical (C), Allergenic (A) or Microbiological (M) hazards that might occur at each stage

2. Critical Control Points (CCP’s)

CCP’s are the stages of your process where the hazards must be controlled for the food to be safe to consume. Example: Cooking, metal detection or pasteurisation

3. Critical Limit

Critical limits are specified safety limits at your CCP’s, which separates acceptable (safe food) from unacceptable (unsafe food). Critical limits are usually measurable values based on scientific finding.

Example: Critical limit for cooking: 80C; Critical limit for pasteurisation = 75.5 C / 15 Seconds / Flow 17000L.

4. Monitoring

Monitoring procedures would need to be established to ensure hazards are controlled at CCP’s. Such monitoring activity may involve temperature checks, visual inspection and time recording

Example:  Checking with a probe thermometer the internal temperature of cooked food; Automatic temperature recording with a probe (within +/- 0.05 C) / filter checks and identifying who is responsible for this (Operators & management)

5. Corrective Action

Corrective actions are procedures to be taken when monitoring (at CCP’s) has identified that the critical limit has been or is likely to be exceeded.

Example:  The act of returning cooked undercooked food to oven (65C) to continue to cook till 80C; Immediate correction: automatic flow divert / RCA: 5 Why / Ishikawa.

6. Verification

This involves taking an overview of your HACCP based system to ensure it is working effectively. It is checking that the checks already done are true and effective at controlling your hazards. Refer to company heat treatment plan (MPI HTST tables).

Example:  Checking the checker activity ; internal audits; Activity (Check such as: temperature, holding time, filters) / Frequency (how often? Daily, weekly or monthly) / Responsibility (who? Operators & management) Verification includes, pasteuriser checks, daily log sheets checks, calibration checks, flow & valve checks and internal audits.

7. Documentation and record-keeping requirements

A HACCP based system must have appropriate documentation to demonstrate it is working effectively. These will usually incorporate HACCP charts, work instructions, written procedures/policies.

Example: Food safety (cooking) records; Pasteuriser records, daily log sheets, calibration records both soft and hard, training records, annual flow & valve checks, internal audits and third-party audits.

Review To ensure the HACCP is working effectively, it is important to review the food safety system at regular intervals. This may be when there is a change of process, flow rate, HACCP plan or a non-compliance related to the current plan.

Website: https://www.foodsafe.net.nz/

More details about our HACCP courses: https://www.foodsafe.net.nz/hazard-analysis-critical-control-point-haccp-training-certificate.html

Other information: https://www.foodsafe.net.nz/blog/entry/haccp-training-nz.html

[ayurvedadoctors-blog]

Herbal health & beauty products at discount

Offering our customers the highest quality #AyurvedicHerbalMedicines, #Ayurvedadoctors.in has brought to you the most trustable line of products in supplements, vitamins, minerals, and enzymes, etc.

Our ayurvedic products carry certifications in organic and kosher practices, as well as known for #GoodManufacturingPractices (GMP) certifications. We aim at maintaining the highest quality-control standards in the herbal industry while formulating our medicines for different problems.

To order these high-quality ayurvedic medicines, visit ayurvedadoctors.In today and get 10% instant discount.

[pmssupplement-blog]

品質と安全性

品質と安全性 #pms #生理不順 #貧血 #生理痛 #オメガ3 #美容 #体質改善 #不妊症 #植物性ミネラル #ミネラルと栄養素は同時に多種類をバランス良く摂らないと働かない #葉酸 #フラン脂肪酸 #酵素

RegaloRicco&Partnersが販売するmirioはGMP認定工場で製造されております。

GMP とは GoodManufacturingPractice の略で適正製造規範といいます。 ・製造工程での人為的な誤りを防止します ・製品の汚染及び品質低下の防止に努めます ・個々の製品に係る品質の均質化を図ります GMPの目的 原料の受け入れから最終製品の出荷に至るまで、適切な管理組織の構築及び作業管理(品質管理・製造管理 )の実施と適切な構造設備の構築により、製品の品質と安全性の確保を図ることです。 なぜGMPか 厚生労働省より、平成17年2月1日付「錠剤、カプセル状等食品の適切な製造に係る基本的な考え方について」(ガイドライン)が示され、原料の受け入れから最終製品の出荷に至るまでの全工程において、製品の品質と安全性の確保に努める必要があるからです。

[montanaemuranch-blog]

Welcome to Testimony Tuesday! Thank you, Rachel! WE appreciate you! Who will be our next big winner of this month's giveaway?! #MontanaemuRanch #Montanaemu #Emuranch #Emu #Emulove #Products #Manufacturing #TestimonyTuesday #DistinctlyMontana #MadeinMontana #MontanaMoment #SENPA #Campaingforsafecosmetics #Smallbusiness #NaturalProductsAssociation #AmericanEmuAssociation #LocalBusiness #Goodmanufacturingpractice #AEACertified #PureEmuOil #EmuOil #GrowninMontana #Arthritis #Musclerub #Natural #Wellness #Health #Supportlocal #Healthandbeauty   https://www.instagram.com/p/B3pJ507BkpF/?igshid=1rqorzthu0lzc