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In the pharmaceutical industry, both Good Documentation Practice (#GDP) and Quality Management System (#QMS) play pivotal roles in ensuring product quality, regulatory compliance, and patient safety. Here's how they relate: Good Documentation Practice (GDP): 1. GDP in the pharmaceutical sector refers to the set of guidelines and practices that govern the creation, maintenance, and control of documents and records. 2. It ensures that documents related to product development, manufacturing, quality control, and distribution are accurate, traceable, and maintained in a secure and organized manner. 3. Proper GDP is crucial for regulatory compliance, audits, and the ability to trace the history of pharmaceutical products. Quality Management System (QMS): 1. QMS is a broader system that encompasses the entire quality control and assurance framework within a pharmaceutical company. 2. It includes policies, processes, procedures, and responsibilities aimed at maintaining product quality, ensuring regulatory compliance, and continuous improvement. 3. QMS is essential for consistently producing high-quality pharmaceutical products and managing risk. GDP is a subset of a pharmaceutical company's QMS, specifically focusing on documentation and record-keeping. Under a comprehensive QMS, GDP ensures that all documents, whether they pertain to manufacturing processes, quality testing, or distribution, are created, maintained, and archived according to strict standards. This is critical for demonstrating #regulatory #compliance, ensuring product quality, and safeguarding patient health in the #pharmaceuticalindustry .

WHO NEWS: Good Practices for Quality Control Laboratories- QAS/21.882 In 1999, the WHO Expert Committee on Specifications for Pharmaceutical Products (#ECSPP) adopted the WHO good practices for national pharmaceutical control laboratories guidelines. These were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002. These guidelines were subsequently revised, renamed as "WHO good practices for pharmaceutical quality control laboratories" and finally published as #Annex1 of the #WHOTechnicalReportSeries, No 957, 2010. Since the last revision of the guidelines, the experience from inspections of #pharmaceuticalqualitycontrollaboratories has enabled WHO to identify sections requiring clarification and the necessity to add new sections. Also, the COVID-19 pandemic has made clear that #riskmanagement, #crisismanagement and #businesscontinuity are subjects which should be addressed to ensure that laboratories are prepared to face similar situations." This guideline is consistent with the requirements of the WHO guidelines for good manufacturing practices and the International Standard #ISO/IEC 17025:2017, providing detailed guidance for laboratories performing quality control testing of medicines. For items 4.3, 4.4, 4.5, 4.6 and 6.7 (Performance evaluation, Risk management, Crisis management, Communication management and Measurement Uncertainty, where applicable), from the new section 4 on “Planning and strategic management”, a period of adaptation from the publication of this document will be given to allow laboratories to properly implement these new requirements. This guideline is applicable to any pharmaceutical quality control laboratory, be it a national quality control laboratory (#NQCL), a commercial quality control laboratory, a third-party contract quality control laboratory or a quality control laboratory of a pharmaceutical manufacturer. The present document provides advice on the #qualitymanagementsystem (QMS) within which the analysis of #pharmaceuticalproducts by quality control laboratories (#QCL) should be performed to ensure that accurate and reliable results are obtained. The document is divided into the following main chapters: 1 General considerations 2 Glossary 3 Organization and management system 4 Planning and strategic management 5 Resources 6 Technical activities 7 Safety rules Appendix 1: Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory Appendix 2: Recommendations for the target uncertainty and the maximum admissible uncertainty for normal analytical practice Appendix 3: Examples of the uncertainty estimation on compliance with normal analytical practice (the "worst case") for assay of pharmaceutical substances by chromatography If you like this post follow me on LinkedIn

Auditing in the pharmaceutical industry is a critical process that ensures compliance with regulatory standards, enhances quality control, and maintains the integrity of manufacturing processes. Here are some key points about pharmaceutical auditing: 1. Regulatory Compliance: Pharmaceutical companies must comply with various regulations and guidelines, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Audits help ensure that these standards are met. 2. Types of Audits: - Internal Audits: Conducted by the company's own staff to assess internal compliance and identify areas for improvement. - External Audits: Performed by regulatory bodies, customers, or third-party auditors to ensure compliance with industry standards and regulatory requirements. - Supplier Audits: Focus on evaluating the practices and quality of suppliers to ensure they meet the required standards. 3. Areas of Focus: - Quality Systems: Reviewing quality management systems, including document control, change control, and corrective and preventive actions (CAPA). - Manufacturing Processes: Ensuring that production processes are in compliance with GMP standards. - Laboratory Controls: Evaluating laboratory practices to ensure the accuracy and reliability of testing and data. 4. Audit Process: - Planning: Defining the scope, objectives, and schedule of the audit. - Execution: Conducting the audit, which includes document review, interviews, and on-site inspections. - Reporting: Documenting findings, identifying non-conformances, and making recommendations for corrective actions. - Follow-up: Ensuring that corrective actions are implemented and effective. 5. Common Findings: - Inadequate documentation - Poorly controlled processes - Non-compliance with regulatory requirements - Incomplete or inaccurate data 6. Benefits: - Ensures product quality and patient safety - Identifies areas for improvement - Reduces the risk of regulatory actions and recalls - Enhances the company's reputation and reliability Regular and thorough auditing is essential in the pharmaceutical industry to maintain high standards of quality and compliance, ultimately ensuring the safety and efficacy of pharmaceutical products.

𝗪𝗛𝗢 𝗗𝗿𝗮𝗳𝘁 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗼𝗻 𝗴𝗼𝗼𝗱 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗳𝗼𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 ✓ World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Products (ECSPP) adopted the WHO good practices for national pharmaceutical control laboratories guidelines which were published as Annex 3 of the WHO Technical Report 92 Series, No. 902, 2002. ✓ These guidelines were subsequently revised and published as Annex 1 of 93 the WHO Technical Report Series, no 957, 2010 and was renamed as "WHO good practices for pharmaceutical quality control laboratories". Since the last revision of the guidelines, the experience from inspections of pharmaceutical quality control laboratories has enabled WHO to identify sections requiring clarification and the necessity to add new sections. ✓ The present document provides advice on the quality management system (QMS) within which the analysis of pharmaceutical products by quality control laboratories (QCL) should be performed to ensure that accurate and reliable results are obtained. Compliance with the recommendations provided in these guidelines will help promote international harmonization of good laboratory practices for pharmaceutical quality control laboratories and facilitate mutual recognition of test results. ✓ This guideline is consistent with the requirements of the WHO guidelines for good manufacturing practices (1) and the International Standard ISO/IEC 17025:2017 (2), providing detailed guidance for laboratories performing quality control testing of medicines. ✓ The good practice outlined below is to be considered as a general guide and it may be adapted to meet individual needs provided that an equivalent level of assurance is achieved. For items section 4.3[ Performance management], section 4.4 [Quality Risk management], section 4.5 [Crisis management], section 4.6 [Communication management] and section 6.7 [Measurement uncertainty] from the new  section 4 on “Planning and strategic management”, a period of adaptation from the publication  of this document will be given to allow laboratories to properly implement these new requirements. #who #qualitycontrol #laboratory #pharmaceuticalindustry #learning #knowledgesharing #gmp

🔍 Exploring Pharmaceutical Quality 🔍 Quality is at the heart of the pharmaceutical industry, ensuring the safety, efficacy, and reliability of medications. Here are some key points to understand about pharmaceutical quality: Definition: Pharmaceutical quality refers to the attributes of a drug product that ensure its safety, efficacy, and consistency. It encompasses all aspects of the manufacturing process, from raw material sourcing to distribution. Regulatory Standards: Regulatory agencies such as the FDA and EMA set stringent standards for pharmaceutical quality. Compliance with these standards is essential for market approval and ensuring patient safety. Quality Systems: Pharmaceutical companies implement quality management systems (QMS) to maintain and improve product quality. These systems include procedures, processes, and resources to ensure consistent quality throughout the product lifecycle. Good Manufacturing Practice (GMP): GMP regulations provide guidelines for the manufacturing, testing, and quality assurance of pharmaceutical products. Compliance with GMP standards is mandatory for pharmaceutical companies. Quality Control: Quality control measures are implemented throughout the manufacturing process to ensure product quality. This includes testing raw materials, in-process samples, and finished products for purity, potency, and stability. Quality Assurance: Quality assurance activities focus on preventing defects and ensuring compliance with quality standards. This includes implementing quality systems, conducting audits, and providing training to personnel. Continuous Improvement: Pharmaceutical companies strive for continuous improvement in quality through processes such as Six Sigma, Lean Manufacturing, and Total Quality Management (TQM). These methodologies help identify and eliminate defects and inefficiencies. Understanding the importance of pharmaceutical quality is essential for ensuring the safety and effectiveness of medications for patients worldwide. #PharmaceuticalQuality #QualityAssurance #GMP #FDA #EMA #PharmaceuticalIndustry

Quality Management Maturity (QMM) Transparent QMM ratings could empower manufacturers to identify ways to improve the effectiveness of their PQSs, realize regulatory flexibilities described in ICH Q10 and help move the pharmaceutical industry toward the six-sigma quality common in other industries (i.e., no more than 3.4 defects occur per million opportunities) Current Good Manufacturing Practice (CGMP) requirements define the minimum manufacturing standards to legally market drug products in the US. The ICH Q10 Pharmaceutical Quality System guidance augments CGMP with the concept of an effective pharmaceutical quality system over the lifecycle of a product. QMM required, in part, thoroughly implementing the concepts of ICH Q10 to promote continual improvement.   The need for QMM ratings does not, however, indicate that substandard drug products are on the market. Quality management is part of an array of quality . The FDA assesses product quality in regulatory submissions and monitors the quality of drug products in the U.S. market to provide a high level of confidence in the quality of these products. The FDA assesses formulation, process, and facility quality in applications and monitors and inspects manufacturing facilities to assure risks are controlled. This level of control assures quality in drug product batches released to the U.S. market. Mature quality management uses a performance and patient focus to identify areas of improvement and implement changes accordingly. This type of management gives manufacturers confidence that every batch they make will be acceptable to release to the U.S. market. Mature quality management assures that quality product is on the market at entry and over the product’s entire lifecycle: quality issues will not keep the product from being available to patients and consumers. Quality management maturity is an expectation in international guidelines (e.g., ICH Q10), but heretofore not actively evaluated by the FDA. An evaluation of QMM is not currently part of the FDA’s assessment, inspection, or surveillance processes; the responsibility for QMM falls solely on the manufacturer

Fun Fact: "Did you know that adherence to GMP (Good Manufacturing Practices) guidelines reduces the risk of product recalls by 50% in the pharmaceutical industry?" Reflecting on my last month in the pharmaceutical industry and studying deeply about Schedule M, I've witnessed firsthand how much GMP is important and how it transforms manufacturing processes. As a professional in the pharmaceutical industry, I now understand the critical role of quality in ensuring the safety and efficacy of medicines. Today, I'd like to shed light on Schedule M, a cornerstone of India's pharmaceutical regulations that focuses on Good Manufacturing Practices (GMP). Schedule M lays out comprehensive guidelines ensuring the highest standards in pharmaceutical manufacturing. It covers various aspects, from facility design, and equipment maintenance, to personnel training and documentation: 1. Facilities and Equipment: Schedule M emphasizes the need for meticulously designed facilities and well-maintained equipment to prevent contamination and ensure product integrity. 2. Personnel and Documentation: Trained personnel following standardized procedures and stringent documentation practices are pivotal in maintaining GMP compliance. 3. Quality Control and Validation: Rigorous quality control testing and validation procedures at different stages of production guarantee consistent product quality and safety. 4. Inspections and Audits: Regular inspections and audits by regulatory authorities are conducted to ensure adherence to Schedule M standards, promoting continuous improvement in manufacturing processes. Understanding and implementing Schedule M standards are crucial not just for compliance but also for delivering high-quality pharmaceuticals that meet global standards. Let's continue our commitment to excellence in pharmaceutical manufacturing by embracing Schedule M's principles and fostering a culture of quality and compliance in our industry. I'm eager to hear your thoughts and experiences with Schedule M! Feel free to share your insights in the comments or connect for a discussion. #ScheduleM #pharmaindustry #pharmaceutical #pharmaceuticals #GMP #PharmaceuticalIndustry #QualityManufacturing #ComplianceMatters #AsianPharma

Sub : Process-Related Impurities (PRIs) and Degradation-Related Impurities (DRIs) Understanding the distinctions between Process Impurities and Degradation Impurities is crucial in pharmaceutical development and quality assurance. These impurities, each with unique characteristics and origins, can significantly impact the safety, efficacy, and stability of pharmaceutical products. Their management is a critical aspect of pharmaceutical manufacturing and is rigorously governed by regulatory guidelines. PRIs are typically identified and quantified during process development and quality control stages. The identification and control of these impurities are crucial for ensuring the purity of the pharmaceutical product and for complying with regulatory standards such as those set by the ICH body. DRIs are primarily a concern during the storage and handling of pharmaceutical products. They are closely monitored through stability testing, which is essential for determining the shelf life and storage conditions of the product. The regulatory guidelines, particularly ICH Q3B, provide a framework for the identification, quantification, and control of DRIs to ensure drug safety and efficacy. In summary, while Process Impurities arise from the manufacturing environment and the materials used in production, Degradation Impurities develop during the storage and life cycle of the pharmaceutical product. Effective management of both types of impurities is essential to meet the quality standards and regulatory requirements of the pharmaceutical industry. #processimpurity #degradationimpurity #PRIs #DRIs #unknownimpurity #impurityprofiling #impurityqualification #impuritycharacterization #impurityisolation #impurityidentification Contact : +91-88888 45450 ; Email-Id : analytical@pharmaffiliates.com

"Are pharmaceutical companies in India ready to meet the government's deadline for adopting WHO-standard Good Manufacturing Practices (GMP)? In a significant move to enhance the quality and safety of pharmaceutical products in India, the government has announced a deadline for pharmaceutical companies to implement WHO-standard Good Manufacturing Practices (GMP). 📅 Deadline for Implementation: Companies with a turnover of over Rs 250 crore will need to implement the revised GMP within the next six months. Medium and small-scale enterprises with a turnover of less than Rs 250 crore will have a slightly extended timeframe of one year to comply. This development underscores the government's commitment to ensuring the highest standards of quality and safety in the pharmaceutical industry. By adopting WHO-standard GMP, companies will not only strengthen their operations but also contribute to the overall trust and reputation of Indian pharmaceuticals on the global stage. The implementation of these practices will undoubtedly lead to:  ✅ Improved product quality  ✅ Enhanced patient safety  ✅ Greater global competitiveness It's a transformative step that will bring our pharmaceutical sector in alignment with international benchmarks. Let's embrace this change and work together to achieve excellence in pharmaceutical manufacturing. 💊🌍 If you're looking for GMP Compliance Support, Please connect on below.     PharmaTeq GMP Solution.        Contact Number:- 6353278772.         E mail :- hello@pharmateqgmp.com  Website: www.pharmateqgmp.com

✋🏻7️⃣ Audit support in the pharmaceutical industry is crucial for ensuring compliance with regulatory requirements, maintaining product quality, and meeting Good Manufacturing Practice (GMP) standards. Pharmaceutical companies are subject to various audits from regulatory authorities, customers, and internal quality assurance teams. Here are some where IncepBio play key aspects for audit support in the pharma industry: 🔍📓Regulatory Audits: Regulatory authorities such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other regional health agencies conduct audits to ensure that pharmaceutical companies comply with GMP regulations and other relevant guidelines. 🔍🗒️Supplier Audits: Pharmaceutical companies frequently conduct audits of their suppliers, including raw material suppliers, contract manufacturers, and service providers. Ensuring that suppliers meet quality standards is essential to maintaining the integrity of the pharmaceutical supply chain. 📝🔍Internal Audits: Internal audits are conducted by a company's own quality assurance team to assess compliance with internal procedures and GMP standards. Regular internal audits help identify and address potential issues before external audits occur. 📚📖Documentation and Record Keeping: Comprehensive documentation is a critical aspect of audit support. This includes maintaining accurate records of manufacturing processes, quality control testing, and all relevant documentation required for regulatory compliance. 📝Training Programs: Ensuring that employees are well-trained and aware of current GMP guidelines is vital for audit support. This includes ongoing training programs for manufacturing personnel, quality control analysts, and other staff involved in pharmaceutical operations. 🔄Continuous Improvement: Audit support extends beyond addressing immediate audit findings. It involves implementing a culture of continuous improvement, where lessons learned from audits are used to enhance processes and prevent recurrence of issues. 🏗️🏥Technology and Automation: Implementing advanced technologies, automation, and data integrity measures can enhance audit support by ensuring accuracy, consistency, and traceability of processes and data. IncepBio helps in Audit support which involves conducting internal Audit, preparing comprehensive documentation, maintaining and ensuring adherence to regulatory guidelines. Get in touch 📧📞 with IncepBio www.incepbio.com soon to minimize the risk during Audit. #audit #support #pharmaceutical #biopharmaceuticals #biotechnology #medicaldevices #regulatorycompliance #suppliermanagement #internalaudit #continuousimprovement #training #documentation #improvement #technology #automation #dataintegrity #guidelines #manufacturing #qc #qa Ajith K Jose ANAND R PILLAI Asish Kumar Prashanth Hugar Ambarish Ghali