#EDQM

[pharmatechy]

Quality Control in Pharmaceutical Industry | QC in Pharma Company

The Quality Control department's major and important role is in the Pharmaceutical industry.

The main role of the quality control department in the pharma industry is to check the quality of various products, such as raw materials, in-process samples, and finished products.

Their main agenda is to analyse and control the quality of the products at all stages of the manufacturing of API or Formulations.

QC is done by the Qualitative and Quantitative analysis of specific materials as per Stanard Testing Procedures (STP) or Method of Analysis.

Generally, the QC department is divided into four sections. These are main

Raw Materials

In-process Quality Checks (IPQC)

Finished Products

Stability Studies

Raw materials:

The materials come from outside industries or suppliers and road tankers check the quality of the materials as per in-house specifications or Standard testing procedures. 

These are categorised into four parts.

General Raw materials:

These are some chemical analyses, like titrimetry, and chemical analysis methods, such as organic and inorganic acids, bases, salts, etc.

Ex: Hydrochloric acid(HCl), Sulphuric acid(H2SO4), Nitric acid(HNO3), Caustic soda(NaOH), Sodium carbonate(Na2CO3), Methanol, Toluene, Acetone, Dichloromethane etc…

Key Starting Materials (KSM):

These are the building blocks of drug intermediates or used to form the structure of compounds, APIs, or Drug substances. 

The sampling method is different from general raw materials.

These are analyzed with both chemical and instrumental analysis.

Ex: Speciality Fine Chemicals, Drug Intermediates etc.

Packing Materials:

PM is used for Products/Compound materials that are stored

Ex: Fibre drums, HDPE, LDPE drums, Polyethene bags, etc…

Hazardous Materials:

HM are harmful or affect body raw materials to handling in careful safety precautions and as per its Material Safety Data Sheets (MSDS) so vendors or suppliers give a certificate of analysis based on these are approved as per customer COAs.

Ex: Sodium Hydride(NaH), Sodium Amide(NaNH2), NaCN etc…

Some catalysts are also approved as per customer COAs

Ex: Raney-Nikel, Palladium/Carbon(Pd/C) used for Hydrogenation reaction.

In-Process samples:

Online chemical and instrumental methods analysis as per in-house specification & STPs carried out samples coming from the manufacturing blocks or production department to time to give results after the process continuously.

Finished Products:

Complete Analysis carried out as per customer or In-house or Pharmacopia specification and Standard Testing Procedures of the final products.

The analysis carried out in the Quality control department is divided into two parts. These are

Chemical Analysis Laboratory (Wet Lab)

Volumetric analysis:

Chemical labs have five types of titrimetric analysis

Acid-Base Titration Ex: Hydrochloric acid (HCl), Sodium Hydroxide (NaOH)

Argentometric titration Ex: Sodium Chloride(NaCl), Aluminum chloride (AlCl3)

Redox Titration Ex: Sodium thiosulphate, Potassium permanganate

Complexometric titration Ex: Calcium chloride (Cacl2), Magnesium (Mg) and Metals

Non-aqueous titration for Drug intermediates and APIs Ex: 2-Amino Pyridine, Isonipotic acid etc..

Gravimetric analysis:

Gravimetric analysis is the mass of an ion in a compound and is determined to find out the mass per cent of the same ion in a known quantity of a compound.

Examples 1) The amount of sulphate as barium sulphate(BaSO4) from sodium sulphate(NaSO4).

2) Content of Nickel in Raney-Nickle catalyst and Palladium in Pd/C catalyst.

Wet laboratory, some important chemical analyses are

Ex: Water content(WC), Loss on drying(LOD), Residue on ignition(ROI), Specific Optical Rotation(SOR), Wt per mL, Thin Layer Chromatography(TLC), Tapped density, Friebilty, Dissolution, Disintegration etc.

Water Analysis:

Softener water: This water is used for boiler purposes to generate steam.

Demineralized or Deionised water: This water is used for chemical analysis and process areas.

Purified water: This water is used for the manufacturing process.

Three samples are collected to be analysed to their specification (WHO) and Standard testing procedures as per scheduled.

Instrumental methods of Chemical analysis

1) Chromatography: 

Instrumental analysis to analyse quantitative and qualitative investigates analytes using the help of scientific instruments.

There are main two instrumental analyses carried out for Quality Control in the Pharmaceutical industry.

This technique separates and identifies the mixture of the compounds based on their relative affinity amounts of each compound distributed between a moving mobile phase, and a stationary phase. Mostly used instruments of Quality Control in the Pharmaceutical industry

          1) High-Performance Liquid Chromatography (HPLC)           2) Gas Chromatography (GC)

2) Spectrophotometry:

Spectroscopic techniques are to pass a beam of electromagnetic radiation onto an unknown sample and observe to find out the difference between energy levels with reference.

Most commonly used spectrophotometers of Quality Control in the Pharmaceutical industry. There are 

           1) Ultra-Violet Spectrophotometer (UVS)            2) Fourier-transform infrared spectrometer (FTIR) and NIR  3) Atomic Absorption Spectrometer (AAS) and FAS

These are the main used Research Centres for Structure elucidations and Analytical Method Development.

          1) Nuclear Magnetic Resonance Spectrometer (NMR)

          2) Mass Spectrometer (MS)

3) Thermo Gravimetric Analysis (TGA)

4) Differential Thermal Analysis (DTA)

Stability Studies:

Stability studies are conducted for a re-test or expiry or a shelf life period for the drug substance or the drug product and recommended storage conditions.

These are analysed as per protocol or stability STP based on the schedule.

           1) Hold-time stability studies            2) Long-term, Accelerated, intermediate condition studies

The quality control department follows systematic proper online documentation, Logbooks, Registers, Good Laboratory Practices (GLP) and Good Documentation Practices.

After complete analysis, documented respective analysis signed and checked authorised persons to prepare the certificate of analysis approved by the Head of the department or Designee.

Backup Electronic Data:

All electronic data stored in their servers or external hard disks are Empower network or Lab solution or Open Lab software and its data is backed up and retrieved every week by an IT person.

 Conclusion:

The Quality Control department checks each step of the product manufacturing as per specification and standard testing procedures after releasing documented data.

[iolcplimited]

Certificate of Suitability (CEP) for Mesalazine

We are delighted to announce that we have been awarded the Certificate of Suitability (CEP) for Mesalazine by EDQM. This globally recognized certification reinforces our dedication to producing high-quality pharmaceutical products that meet international standards and improve lives worldwide. We extend our deepest gratitude to our incredible team, whose commitment and hard work made this achievement possible. Together, we continue our journey of excellence in healthcare innovation.

[pharmawalksjobs]

Ind-Swift Limited walk-in interview for Packing department on 28th Dec 2024

Ind-Swift Laboratories Ltd., based in Chandigarh, India, has positioned itself as a leading worldwide producer of APIs, Intermediates, and formulations through collaborative endeavors. With operations at more than 6 regulated manufacturing facilities, including 2 group subsidiaries in Punjab and Jammu, we are committed to fulfilling the API needs of regulated markets like USFDA, EDQM, PMDA,…

[sainorlabs]

Pellets Exporters in India

India has emerged as a significant player in the global pharmaceutical industry, with a growing demand for high-quality pellets for diverse medical applications. Sainor Labs, a leading name in the pharmaceutical manufacturing sector, has established itself as a reliable and reputable pellets exporter in India. With cutting-edge technology, strict adherence to quality standards, and a customer-centric approach, Sainor Labs ensures consistent supply and top-notch products to meet global demands.

What Are Pharmaceutical Pellets?

Pharmaceutical pellets are small, free-flowing, spherical or semi-spherical granules typically used in controlled-release formulations. These pellets provide uniform drug distribution, enhanced bioavailability, and improved patient compliance, making them an essential component in modern drug delivery systems.

Pellets are widely used in:

Extended-release drug formulations

Immediate-release dosage forms

Taste masking of bitter drugs

Combination therapies for efficient treatment

Why Choose Sainor Labs as Your Pellets Exporter in India?

State-of-the-Art Manufacturing Facilities

At Sainor Labs, we utilize advanced technology and modern machinery to manufacture pharmaceutical pellets that meet global regulatory standards. Our facilities are GMP-compliant, ensuring clean and consistent production practices.

Stringent Quality Control

Quality is the cornerstone of our operations. We implement rigorous quality control measures across every stage of production – from raw material procurement to final product packaging. Our quality assurance team conducts comprehensive testing to ensure the purity, safety, and efficacy of the pellets.

Customized Solutions

We understand that every client has unique requirements. Sainor Labs offers customized solutions to cater to diverse market demands, including tailored pellet size, drug layering, and release profiles to suit specific formulations.

Global Presence

As a trusted pellets exporter in India, Sainor Labs has built a strong global footprint. We supply pharmaceutical pellets to clients across the USA, Europe, Asia, and other regions, adhering to international standards like USFDA, EDQM, and WHO-GMP.

Sustainability & Reliability

Sainor Labs believes in responsible manufacturing practices. By focusing on sustainability and ethical operations, we ensure reliable, long-term partnerships with our clients worldwide.

Range of Pellets Offered by Sainor Labs

Sainor Labs specializes in manufacturing a broad range of pharmaceutical pellets, including:

Sustained-Release Pellets: Designed to provide controlled drug release over a specific period.

Immediate-Release Pellets: Formulated to release active pharmaceutical ingredients instantly.

Enteric-Coated Pellets: Designed to bypass the stomach and dissolve in the intestinal tract.

Combination Pellets: Allow multiple drugs to be combined for enhanced therapeutic effects.

Why India Is a Key Exporter of Pellets

India’s pharmaceutical industry benefits from a strong talent pool, cost-effective production, and adherence to international regulatory standards. These factors position India as a global hub for pharmaceutical exports, including high-quality pellets. Sainor Labs has harnessed this potential to become a leading pellets exporter, delivering excellence to international markets.

Partner with Sainor Labs for High-Quality Pellets

Sainor Labs continues to set benchmarks in pharmaceutical pellet manufacturing and exports. Our commitment to quality, innovation, and customer satisfaction makes us the preferred choice for pharmaceutical companies worldwide.

If you are seeking a reliable partner for pharmaceutical pellets exports in India, Sainor Labs is your trusted solution. Contact us today to explore how we can meet your requirements with precision and excellence.

[digitalservices99]

Linagliptin API Manufacturers

The pharmaceutical industry continuously evolves to meet the rising demands for effective treatments for chronic conditions such as Type 2 diabetes. Among the various solutions available, Linagliptin, a DPP-4 inhibitor, has gained prominence for its role in managing blood sugar levels. As a key component in diabetes medications, the Active Pharmaceutical Ingredient (API) of Linagliptin must meet stringent quality standards to ensure patient safety and therapeutic efficacy. Actis Pharma stands out as a leading name in the manufacturing of Linagliptin API, ensuring excellence at every stage of production.

Why Linagliptin API Matters

Linagliptin works by inhibiting the enzyme DPP-4, which helps increase the levels of incretin hormones in the body. These hormones stimulate insulin release and decrease blood sugar levels. As a widely used treatment for Type 2 diabetes, the demand for high-purity Linagliptin API has surged. Reliable API manufacturers like Actis Pharma play a pivotal role in enabling pharmaceutical companies to formulate effective medications.

Actis Pharma: A Trusted Manufacturer of Linagliptin API

With years of experience and a commitment to innovation, Actis Pharma has established itself as a trusted name in API manufacturing. Here’s what sets Actis Pharma apart in the production of Linagliptin API:

State-of-the-Art Facilities Actis Pharma employs cutting-edge technology and advanced manufacturing facilities that comply with international quality standards, such as GMP (Good Manufacturing Practices) and ISO certifications. These facilities ensure the production of high-purity Linagliptin API.

Stringent Quality Control The quality of APIs directly impacts the safety and efficacy of the final pharmaceutical product. Actis Pharma adheres to rigorous quality control processes, including analytical testing and stability studies, to ensure the highest standards of product consistency.

Expertise in Chemical Synthesis Linagliptin API requires complex synthesis processes that demand expertise and precision. Actis Pharma’s team of experienced chemists and researchers employs proprietary methods to optimize yields while maintaining eco-friendly practices.

Global Compliance Actis Pharma’s Linagliptin API complies with various regulatory requirements, including USFDA, EDQM, and WHO GMP standards. This makes their products suitable for pharmaceutical markets across the globe.

Sustainable Practices Understanding the need for environmentally responsible operations, Actis Pharma incorporates green chemistry principles in its manufacturing processes, reducing waste and minimizing the environmental footprint.

Benefits of Choosing Actis Pharma

Pharmaceutical companies partnering with Actis Pharma for Linagliptin API gain access to several benefits:

Consistent Supply Chain: With robust manufacturing capabilities, Actis Pharma ensures timely delivery of APIs to meet industry demands.

Customizable Solutions: Actis Pharma works closely with clients to develop tailored solutions that meet specific formulation requirements.

Cost Efficiency: Competitive pricing without compromising quality makes Actis Pharma a preferred choice for Linagliptin API.

Driving Diabetes Treatment Forward

Actis Pharma’s dedication to innovation, quality, and sustainability positions it as a leading player in the Linagliptin API market. By providing high-purity and reliable APIs, the company supports global efforts to improve diabetes care and enhance the quality of life for millions of patients worldwide.

Conclusion

In the competitive landscape of API manufacturing, Actis Pharma distinguishes itself through its unwavering commitment to quality, compliance, and innovation. As a trusted Linagliptin API manufacturer, the company continues to contribute to advancements in diabetes treatment, empowering pharmaceutical companies to deliver effective and safe medications.

If you're seeking a dependable partner for high-quality Linagliptin API, Actis Pharma is the name you can trust. For more information, connect with their expert team and explore how they can cater to your API requirements.

[forblogmostly]

Sigachi Industries Announces CEP Filing for Propafenone Hydrochloride

Sigachi Industries Limited, a prominent name in the pharmaceutical industry, has announced a significant milestone in its journey toward global market expansion. The company's subsidiary, Trimax Biosciences Pvt. Ltd., has received communication from the European Directorate for the Quality of Medicines & Health Care (EDQM) regarding its recent Certificate of Suitability (CEP) filing for Propafenone Hydrochloride, a high-demand Active Pharmaceutical Ingredient (API).

About Propafenone Hydrochloride Propafenone Hydrochloride is widely used in the treatment of cardiac arrhythmias, a condition affecting millions globally. The API currently commands a global market size of USD 1.2 billion, with growth projections estimated to reach USD 2.1 billion by 2032, reflecting a robust CAGR of 7%. Factors such as increasing cardiovascular disease prevalence, growing generic adoption, and rising healthcare expenditures contribute to this market's dynamic growth.

Strategic Importance This submission marks a pivotal achievement for Sigachi Industries and Trimax Biosciences in several ways:

Regulatory Compliance: The CEP ensures adherence to stringent European regulatory standards, enabling the company to export this API across Europe and other CEP-compliant regions. Market Diversification: This development is set to diversify Sigachi’s revenue channels, enhancing value for its stakeholders. Commitment to Quality: By delivering products aligned with the highest quality standards, the company reinforces its reputation for excellence in highly regulated markets. Leadership Insights Amit Raj Sinha, Managing Director and CEO of Sigachi Industries Limited, stated: "The submission of our first CEP filing is a testament to Trimax Biosciences’ commitment to quality, compliance, and innovation in the API domain. This achievement strengthens our position in the pharmaceutical supply chain and aligns with our vision of providing reliable and sustainable pharmaceutical solutions globally."

Trimax Biosciences: A Sigachi Group Company Founded in 2010 and based in Raichur, Karnataka, Trimax Biosciences specializes in the development and manufacturing of APIs, intermediates, and advanced intermediates. Its state-of-the-art facility, compliant with USFDA, cGMP, EMEA, and WHO-GMP guidelines, underscores its dedication to global quality benchmarks. With a focus on critical and advanced intermediates, Trimax continues to play a crucial role in modern healthcare solutions.

Future Outlook The CEP filing for Propafenone Hydrochloride signals Trimax Biosciences’ readiness to scale its operations in international markets. Sigachi Industries is committed to pursuing similar high-growth opportunities in the pharmaceutical space, ensuring sustained innovation and compliance to meet evolving global health needs.

[sunalimerchant]

Top Palbociclib API Manufacturers in 2024: A Comprehensive Guide for Pharma Professionals

Palbociclib, a breakthrough molecule in cancer therapy, has revolutionized the treatment of metastatic breast cancer. As a cyclin-dependent kinase (CDK) inhibitor, Palbociclib works by halting the uncontrolled proliferation of cancer cells, making it a critical component in combination therapies. The demand for high-quality Active Pharmaceutical Ingredients (APIs) for Palbociclib has surged, driving innovation and competition among global manufacturers.

For pharmaceutical companies seeking reliable Palbociclib API suppliers, understanding the market leaders is essential. This article explores the top Palbociclib API manufacturers in 2024, their offerings, and what sets them apart.

1. Aarti Pharmalabs

Overview: Aarti Pharmalabs is a prominent player in the pharmaceutical manufacturing industry, known for its high-quality API production. The company focuses on delivering premium-grade Palbociclib APIs that meet stringent international standards, including USFDA and EU-GMP compliance.

Key Strengths:

Advanced manufacturing facilities with state-of-the-art technology.

Commitment to sustainability and eco-friendly processes.

Robust quality assurance systems ensuring consistent product quality.

Why Choose Aarti Pharmalabs: Their strong focus on innovation and compliance makes them a reliable partner for pharmaceutical companies looking to source Palbociclib APIs for global markets.

2. Dr. Reddy’s Laboratories

Overview: Dr. Reddy’s Laboratories is a globally recognized name in the pharmaceutical sector. With decades of experience, the company has a strong API portfolio, including Palbociclib. Their emphasis on research and development ensures cutting-edge manufacturing processes.

Key Strengths:

Expertise in large-scale production and global distribution.

Adherence to regulatory standards across multiple countries.

Strong supply chain infrastructure ensuring timely delivery.

Why Choose Dr. Reddy’s: Their ability to scale production without compromising quality makes them a preferred choice for large pharmaceutical enterprises.

3. Cipla Limited

Overview: Cipla is another industry leader known for its high-quality APIs, including Palbociclib. The company focuses on making life-saving drugs accessible through cost-effective manufacturing processes and strategic partnerships.

Key Strengths:

Extensive global footprint with operations in over 80 countries.

Compliance with international quality and regulatory requirements.

Affordable pricing models catering to both large and small-scale pharmaceutical companies.

Why Choose Cipla: Cipla’s balance of affordability and quality positions them as a competitive choice for companies looking to reduce costs without compromising product efficacy.

4. Divi’s Laboratories

Overview: Divi’s Laboratories is a leading manufacturer of APIs with a strong focus on innovation and sustainability. Their Palbociclib API production is backed by rigorous research and a commitment to excellence.

Key Strengths:

World-class manufacturing facilities with regulatory approvals from USFDA, WHO, and EDQM.

Focus on green chemistry and sustainable manufacturing.

Strong customer support and technical assistance.

Why Choose Divi’s Laboratories: Their reputation for innovation and eco-friendly practices makes them a reliable partner for businesses emphasizing sustainability.

5. Sun Pharma

Overview: Sun Pharma, one of the largest pharmaceutical companies globally, has a diverse portfolio of APIs, including Palbociclib. Their commitment to research-driven innovation ensures products that meet global standards.

Key Strengths:

Extensive R&D capabilities driving product improvement.

Large-scale production capacity to meet high-volume demands.

Comprehensive quality control processes ensuring consistency.

Why Choose Sun Pharma: Their global reach and production expertise make them an ideal partner for companies targeting international markets.

What to Look for in a Palbociclib API Manufacturer

When selecting a Palbociclib API manufacturer, pharmaceutical companies should consider the following factors:

Regulatory Compliance: Ensure the manufacturer adheres to international standards such as USFDA, WHO, and EU-GMP.

Production Capacity: The ability to meet large-scale production demands is crucial for sustained supply.

Quality Assurance: Consistent product quality backed by thorough testing and validation processes.

Technical Support: A reliable manufacturer provides post-sales technical assistance for seamless integration into drug formulations.

Cost-Effectiveness: Competitive pricing without compromising quality ensures long-term viability.

Conclusion

The demand for high-quality Palbociclib APIs continues to grow, driven by the increasing prevalence of cancer and advancements in oncology treatments. Leading manufacturers like Aarti Pharmalabs, Dr. Reddy’s Laboratories, Cipla, Divi’s Laboratories, and Sun Pharma have established themselves as reliable suppliers, meeting global standards with excellence.

For pharmaceutical companies, partnering with the right API manufacturer is critical to ensuring product efficacy, regulatory compliance, and cost efficiency. By focusing on quality, innovation, and sustainability, these manufacturers are setting new benchmarks in the production of Palbociclib APIs. Explore options like Aarti Pharmalabs to secure a trusted supply chain partner for your pharmaceutical needs.

[synnatpharma11]

Sertraline Mandelate Intermediates Manufacturer

Sertraline Mandelate Intermediates Manufacturer

Sertraline Mandelate is utilized for treating depression, depressive disorders, obsessive-compulsive disorder, panic disorder, and similar conditions. It enhances mood, thereby reducing the impact of these conditions and helping restore normal functioning by rebalancing serotonin levels in the brain.

India serves as a hub for numerous manufacturers of sertraline mandelate intermediates, as well as a wide range of APIs and intermediates for various medical applications. These companies specialize in the bulk production and distribution of high-quality pharmaceuticals for both domestic and international clients, adhering to stringent quality standards.

While securing a reliable sertraline mandelate intermediates supplier may be relatively straightforward due to the number of companies in the field, finding a long-term partner that can adapt to your evolving business needs can be more challenging.

We would like to introduce Synnat Pharma, an internationally recognized company specializing in APIs and intermediates with a presence in over 30 countries. Despite being in the industry for just over a decade, we have gained the trust and confidence of our clients by staying true to our vision: providing effective medical solutions at compelling prices. We comply with multiple quality standards, including WHO, EDQM, CDSCO, and PMDA, reflecting our commitment to excellence.

Choose Synnat Pharma not only because we are among the leading manufacturers of sertraline mandelate intermediates, but also because we are dedicated to advancing healthcare by delivering innovative medical solutions that shape the future of the industry.

[sudheervanguri]

Amoli Organics Walk-In Drive for Production and Quality Control Amoli Organics, a division of Umedica Laboratories Pvt. Ltd., is hosting a walk-in drive for various positions in Production and Quality Control at its Vapi Plant. This is a prime opportunity for individuals with qualifications in BSc Chemistry, MSc Chemistry, or ITI to advance their careers with a company known for its expertise in Active Pharmaceutical Ingredients (APIs) manufacturing. About Amoli Organics Established in 1992, Amoli Organics has grown to become a leading manufacturer of APIs, collaborating with global healthcare leaders. With state-of-the-art facilities in Mumbai, India, the company meets the stringent standards of the global pharmaceutical industry, having received approvals from EDQM and USFDA. Amoli Organics is dedicated to innovation, quality, and expanding its global footprint in the healthcare sector. Available Positions in Production and Quality Control 1. Production Department Officer / Sr. Officer Qualification: MSc Chemistry, B.E, B Tech Chemical, BSc Chemistry Experience: 0-5 years Skills Required: Knowledge of API Plant operations, equipment handling, GMP compliance, and good documentation practices. Tr. Associate / Associate Qualification: BSc Chemistry, ITI AOCP Experience: 1-3 years Skills Required: Experience in API Plant operations, equipment handling, GMP knowledge, and good documentation practices. Apprentice Qualification: BSc Chemistry, ITI AOCP Experience: Fresher Vacancies: 20 Responsibilities: Gain hands-on experience in API Plant operations, learn equipment handling, and understand GMP documentation. [caption id="attachment_100528" align="aligncenter" width="930"] Amoli Organics Announces Walk-In Drive for Production and Quality Control[/caption] 2. Quality Control Department Officer / Executive / Sr. Executive Qualification: MSc Analytical/Organic Chemistry Experience: 2-7 years Skills Required: Proficiency in HPLC, GC, Autotitrator, UV, FITR, Chromeleon 7.2, Lab Solution, and Tiamo software. Jr. Associate / Associate Qualification: BSc Chemistry, ITI LACP Experience: 0-2 years Skills Required: Knowledge of sampling of raw materials, API, and intermediates. Walk-In Drive Details Interview Dates: 6th September 2024 & 8th September 2024 Time: 10:00 A.M. to 3:00 P.M. Venue: Amoli Organics, Plot No. 322/4, 40 Shed Area, GIDC, Vapi-396195

[ihspl]

Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

[formiforma]

🚀 Plus besoin de chercher partout. Nous avons rassemblé les ressources essentielles pour vous dans un site convivial et intuitif, car Formi Forma  est devenu l'univers de la Connaissance en un Seul Endroit! 🌐, Alors sans perdre du temps : 🔍 Plongez dans nos Guides et Référentiels Pharmaceutiques en un seul clic : 💊 ANSM - Documents de référence ��� 💊 FDA - Guides et réglementations 🇺🇸 💊 IPEC - Guides et documentations des excipients 💡 💊 ICH - Guides pour l'harmonisation internationale 🌐 💊 USP - Catalogue des substances de référence 📚 💊 EDQM - Catalogue des étalons de référence 🌍 💊 BP - Étalons de référence de la Pharmacopée Britannique 🇬🇧 💊 MIPH - Ministère de l'Industrie Pharmaceutique 🏭 💊 PIC/S - Documentations 🧪 📚 Explorez nos Guides et Référentiels Alimentaires sans quitter la page : ✅ FDA - Produits alimentaires et nutrition 🇺🇸 ✅ CODEX - Normes alimentaires internationales 🌍 ✅ LNE - Normes et référentiels pour le contact alimentaire 🧪 ✅ ANSES - Sécurité sanitaire de l’alimentation 🛡️ ✅ CODEX - Publications officielles 📘 🚀 Innovez votre recherche, simplifiez votre expertise! 💡 Rejoignez-nous sur www.formiforma.com et transformez la façon dont vous accédez à la connaissance. Ensemble, découvrons un univers de ressources, au même endroit, tout de suite! 🚀

[pharmawalksjobs]

Ind-Swift Limited walk-in interviews for Packing, QA, QC on 14th Dec 2024

Ind-Swift Laboratories Ltd., based in Chandigarh, India, has positioned itself as a leading worldwide producer of APIs, Intermediates, and formulations through collaborative endeavors. With operations at more than 6 regulated manufacturing facilities, including 2 group subsidiaries in Punjab and Jammu, we are committed to fulfilling the API needs of regulated markets like USFDA, EDQM, PMDA,…

[aartipharmalabs]

Serving our global clients with our full spectrum of services for their API and Drug Substance Manufacturing needs

Aarti Pharmalabs specializes in the clinical phase and commercial production of APIs and NCEs, Intermediates, Regulatory Starting Materials, Key Building Blocks and Xanthine Derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production.

Our operations include 2 R&D centers and 6 manufacturing facilities and our 3 cGMP pharmaceutical products manufacturing plants have been successfully audited by USFDA, EUGMP, EDQM, KFDA and COFEPRIS etc.

[serresvoice]

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Στην ανάκληση φαρμάκων προχώρησε ο ΕΟΦ, μετά και τις ενέργειες του ευρωπαϊκού οργανισμού EDQM που απέσυρε το πιστοποιητικό καταλληλότητας για τη δραστική ουσία βαλσαρτάνη, που παράγεται από το εργοστάσιο Zheijiang Tianyu Pharmaceutical Co Ltd (Κίνα).

Η επανεξέταση από τον Ευρωπαϊκό Οργανισμό Φαρμάκων της βαλσαρτάνης σε σχέση με το NDMA συνεχίζεται και ο Οργανισμός συνεργάζεται στενά με την…

[luigiderosa]

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.

The report presents the results of the multinational validation study aimed at validating 4 basic sets of indicators to assess the quality of pharmaceutical care in Europe. It also contains the data collection forms that were developed and used in the above validation study. This report will…