- Investigation is the process of. Collecting and analysing data to determine the cause of non- compliance or failure. In pharmaceutical industry, failure or. Non-conformity may arise due to many reasons.
- According to a report by the FDA (FY2010), the third most common reason for a 483 (violation) was because of inadequate content of investigations or not completing an investigation in a timely manner.
- One of the most common mistakes made by the writers of these reports was incomplete investigations which led to poorly written investigations.
- The FDA requires an investigation to be meaningful, thorough, timely, unbiased, well-documented, and scientifically sound.
- In order to comply with regulations, it is important to hold an investigative report writing session for the employees of Pharmaceutical Industry to improve the quality of investigative reports writing.
GMP Workshops
1. Investigation Report Writing & Documentation
2. Handling of GMP Audits (Do’s & Don’ts)
- GMP Audit is governed by the fundamental principles of Good Manufacturing Practice (GMP) which serve to ensure quality, efficacy and safety of medicinal products.
- Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor’s assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
- This workshop includes a supplemental module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge with Do’s & Don’ts while handling of audits.
3. Practical Approaches to Quality Metrics for Pharmaceutical R & D And Manufacturing
- Quality metrics are a key component of an effective quality management plan and are the measurements used in ensuring customers receive acceptable products or deliverables. Quality metrics are used to directly translate customer needs into acceptable performance measures in both products and processes.
- The workshop has been compiled to introduce the various aspects and basics of quality metrics, its need and benefits in assuring quality production.
- It includes the USFDA’s proposed Quality Metrics program, assess the anticipated burden of metrics as defined by the FDA in the 2015 Request for Quality Metrics draft Guidance.
- It covers statistically significant relationship between quality metrics and quality outcomes as revealed by the ISPE Quality Metrics Pilot Program.
- In addition, the course also covers the main elements of the Quality Management System needed to provide medicines of the highest quality, including the requirements for documentation, training and system monitoring and review.
4. Train The Trainer for Pharmaceutical & Biopharmaceutical Organization
- Although it may appear to be simple, conducting a training session requires specific skills and knowledge of how people learn. Trainers who have taken the time to consider their own approaches, understandings, and skills will be better equipped to provide comprehensive, active and effective training courses. This training program provides the groundwork for trainers to begin developing and refining their training and facilitation skills using a variety of methods to deliver the best learning experiences and improve learner engagement and retention. Over time, trainers will develop their practical skills further because of this workshop.
- The workshop has been compiled to different modules like roles and responsibilities of a professional trainer, principles of adult learning, Training design and methods dealing with tough training times etc.
- This course is intended for subject matter experts who wish to transition into training professionals in their areas of expertise. This course is also designed for anyone interested in learning more about adult learning and training.
5. Introduction to Quality & Good Manufacturing Practices
- The quality in the pharmaceutical industry has become a very important topic. Since the world has gathered together to harmonize its practices and guides and the launching of the FDA current good manufacturing practices – the cGMP; for the 21st century – there has been a growing awareness for the significance of the quality of the pharmaceutical products.
- It Includes :
- Guidelines of the pharmaceutical quality.
- General practices recently applied in the pharmaceutical industry.
- The workshop covers the overview of main guidelines: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines for Quality products and GMP.
- It also covers GMP general guidelines following elements such as Personnel, Premises, Sanitation, Equipment, Starting Materials, Production, Quality Control, Self-Inspection, Handling of product complaint, product recall and returned drug products and Documentation.
6. Workflow in Good Manufacturing Practices
- Good manufacturing practices are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices
- GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GMP—
- People,
- Premises,
- Processes,
- Products and
- Procedures (or paperwork).
- And if all five are done well, there is a sixth P … Profit!
- It covers workflow of People, Premises, Processes, Products, and Procedures according to cGMP guidelines.
7. Understanding Quality Management System – Part (1 & 2)
- Quality management system in pharmaceuticals helps to improve the product quality and minimize the risk of product recall. Quality Management System a set of interacting elements based on procedures, policies, resources, and objectives that are established collectively to guide an organization.
- A properly designed and implemented QMS makes customer satisfaction a priority. It requires that customer feedback be encouraged from multiple sources, and that this information be managed and used to improve customer satisfaction.
- QMS assist the design and development processes in the pharmaceutical industry to ensure that the resulting products meets the agreed specification.
- QMS covers Process performance and product, quality monitoring system, Corrective action and preventive action (CAPA) system, Change management system, Management review of process, performance and product quality.
8. Understanding Qualification and Validations – Part (1 & 2)
- Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines. Pharmaceutical facilities consist of various processes, each of which must be accurate to ensure that the end product is of high quality.
- Validation is an integrated process in the pharmaceutical industry as it is mandatory to comply with national and international standards of FDA and EMA. Validation ensures that all the processes are in compliance with the established cGMP standards.
- This workshop will cover the broad aspects of area qualification, equipment qualification and process validation etc.
- In addition, Importance of Qualification and validation in Quality control, Production and Utility department of Pharmaceutical Industry.
9. Data Integrity in Elements of Quality Management System
- USFDA suggests that data integrity refers to the completeness, consistency, and accuracy of data, which should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. USFDA suggests that adherence to the data integrity is must to ensure the cGMP compliance.
- The workshop will focused on basic principles of data integrity based on regulatory guidelines.
- It will also cover ALCOA data integrity principle which means that data should be: Attributable, Legible, Contemporaneous, Original, and Accurate in detail.
10. Integration of Pharmaceutical Development, Quality Risk Management, & Pharmaceutical Quality Management System
- Quality Risk Management is an overall and continuing process of minimizing risks to product quality throughout its life-cycle in order to optimize its benefit and balance the risk. It is a systematic process for the evaluation, control, communication and review of risks to the quality of the medicinal product.
- Analysis of risk based on different tools and techniques.
- Understand the quality risk management based on guidelines.
- Risk management is now a days, basic requirements for all companies and it’s also a part of ISO.
11. GMP for Active Pharmaceutical Ingredients (Q7) & its integration with development and manufacturing of Drug Substances (Q11)
- ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
- The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
- The ICH guidance Q11 describes approaches to development and manufacture of drug substances (Chemical entities and Biotechnological/biological entities)
- ICH Q7 includes Quality Management, Personnel, Building & Facilities, Process equipment, Documentation and records, material management, production and in-process control, packaging and identification labelling of API and intermediates, storage and distribution, Laboratory control, Validation, change control, rejection and reuse of materials, complaints and recalls etc.
- ICH Q 11 includes manufacturing process development, process controls, selection of starting material and source material, control strategy, process validation/evaluation, CTD, lifecycle management etc.
12. GMP for supply chain Management, Human Resource Management & Engineering Management (GEP)
- Supply chain management is in the sense for Raw Material, Packing Material Procurement. Based on Production Planning Supply Chain team will procure required qty. of material from Approved Vendor.
- GMP for Supply Chain includes source of new quality product, vendor, Material procurement on time to execute planned production, continuity of required Material, chemicals or any other plant requirements, and their support in documentation and audit.
- Human Resource Management is responsible to provide technical & required Staff (Fresher or Experienced) to respective department, To arrange interview of shortlisted candidates, their follow up & documentation, HR is also responsible for Exit Interview and employee’s reliving process.
- Engineering team is having multiple tasks in their routine Job description. As their main responsibilities are: to provide required utility to plant personnel, power supply to plant, equipment installation, any failure or trouble shoot occurred in plant, Preventive maintenance of equipment, instruments and facility, Building management and more.
- This workshop will cover all broad aspects of supply chain management, HR management and Engineering Management (GEP) as per guidelines and requirement of regulatory.
13. Application of Quality Metrics in determining Overall State of Quality & the Health of Associated PQS- ‘FDA’s Current thinking’
- Note: Please refer workshop No. 3 OR
- Quality metrics are a key component of an effective quality management plan and are the measurements used in ensuring customers receive acceptable products or deliverables. Quality metrics are used to directly translate customer needs into acceptable performance measures in both products and processes.
- The workshop has been compiled to introduce the various aspects and basics of quality metrics, its need and benefits in assuring quality production.
- It includes the USFDA’s proposed Quality Metrics program, assess the anticipated burden of metrics as defined by the FDA in the 2015 Request for Quality Metrics draft Guidance.
- It covers statistically significant relationship between quality metrics and quality outcomes as revealed by the ISPE Quality Metrics Pilot Program.
- In addition, the course also covers the main elements of the Quality Management System needed to provide medicines of the highest quality, including the requirements for documentation, training and system monitoring and review.
14. Setting of Specification, Acceptance Criteria, & Role of AQL
- As per Regulatory guideline, all Raw Material, Packing Material, In-process samples & finished product is having their own specification for analysis of samples. Based on R & D, F & D and technology transfer testing parameter documentation and method, Specification is developed and followed for routine analysis.
- Acceptance criteria for each analysis must as per Pharmacopeia or as per Developed Validated method.
- AQL = Acceptance Quality Level, AQL is applied at different stages but before applying AQL you have to find rational for applying AQL. AQL is based on History Trend Data, Risk Management Data, Management Approval & robust process results. AQL is applied to reduce process time and more output.
- In addition, it will also covers advantages and challenges of AQL in pharmaceutical industry.
15. GMP for Excipient Manufacturer – Mandatory for European Experts
- An excipient is any constituent of a medicinal product other than the active substance and the packaging material.
- GMP for API or Excipients is we can consider as same because GMP everywhere remains same for Data Integrity, Continuous Improvement & Best Product Quality.
- Especially for Europe market European Medical Agency (EMA) has published detailed guideline for manufacturing of Excipients for which used for Europe Export.
- Certificate of Suitability (CEP) must be available with manufacturer those who want to export their product in Europe market. CEP Grade material is only allowed to export in Europe region, and for this certificate manufacturer has to submit product’s DMF to EDQM.
- Determination of Appropriate GMP based on type and use of excipient, risk profile and confirmation of application of GMP
16. How to conduct stability Studies to avoid Warning Letters
- Stability is how much the product remains in established parameters at the established conditions and needed shelf life. As most of us know, behind every date of expiration for a drug is supposed to be ample stability testing
- According to FDA leaders, stability is a very common source of 483 observations and warning letters.
- Stability testing of drug products is required by 21 CFR 211.166 of the cGMP and ICH guidelines. The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light, and enables recommended storage conditions, re-test periods and shelf lives to be established.
17. Technology Transfer – Structured Process
- In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner.
- Each type of tech transfer project presents its own set of unique risks: When transferring a new process from the lab to the plant, new unit operations, different raw materials and new assays may be required. New processes must be well developed and understood (i.e., characterized) before they are transferred to manufacturing. This will require extra time, and may delay the initial transfer to manufacturing, but will speed up the overall process and the time it takes to achieve the overall objective.
- Finally, it is important to define what is meant by “successful” transfer. The ultimate success of a Technology Transfer should be a success of the first GMP manufacturing campaign.
18. Design & Management of Microbiology lab in Regulated Environment
- The most important contribution of microbiology to the pharmaceutical industry is the development of antibiotics, Vaccines & development of drugs. Apart from drugs and bio products development, microbiology contributes towards quality control of a pharmaceutical laboratory. Prevention of microbial contamination of drugs, injectable, eye drops, nasal solutions and inhalation products is undertaken following pharmacopeia guidelines.
- The design of a microbiology laboratory set up needs to address physical separation of spaces to carry out functions and meet safety, environmental, and other requirements in accordance with cGMP regulations.
- There is basic requirements for any microbiology lab is Facility, equipment set up, ventilation , the human factor, hygiene, entry and exit, controlled area for specific testing like sterility, separate area for microbial testing, media preparation, incubation area etc. for regulatory purpose.
19. Quality culture – Charting the Path
- Quality Unit (QA & QC) is responsible to develop a good quality culture in organization.
- Quality Policy, Data Integrity Policy, Training Policy, HR Policy, Employee Welfare Policy must be designed at its best level and must be followed by each individual employee in the organization.
- Quality culture is must for all organization to maintain Product Quality, Employee Stability, and Reputation in Market, Company + Employee growth etc.
20. The theory & Practice of Industrial Pharmacy
- Industrial Pharmacy is a discipline which includes manufacturing, development, marketing and distribution of drug products including quality assurance of these activities.
- It includes most of the area of pharmaceuticals, basic concepts of drug, types of dosage forms, Active pharmaceutical ingredients, Excipients etc.
21. FDA’s expectation for Analyst Qualification, Requalification & Analytical Method Validation
- Quality Unit (QA & QC) is responsible to develop a good quality culture in organization.
- Quality Policy, Data Integrity Policy, Training Policy, HR Policy, Employee Welfare Policy must be designed at its best level and must be followed by each individual employee in the organization.
- Quality culture is must for all organization to maintain Product Quality, Employee Stability, and Reputation in Market, Company + Employee growth etc.
22. Process Validation and Cleaning Validation
- Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as the manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its predetermined specifications and quality characteristics. It includes qualification of facility, utilities and equipment.
- Cleaning Validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. The main purpose of validating a cleaning process is to ensure compliance with standard regulatory authorities and the identification and correction of potential problems previously unsuspected, which could compromise the safety, efficacy or quality of subsequent batches of drug product produced within the equipment.
23. CVS – Gamp 5 – Data Integrity – 21 CFR Part 11 & EU Annexure 11 Compliance
- Computer system validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for pharmaceutical industry.
- CSV is a documented process for assuring that a computer system does what it is designed to do. Both the European Medicines Agency (EMA) and the Food & Drug Administration (FDA) have produced guidelines for CSV practices.
- All computer system based equipment/instrument must be validated as per 21 CFR part 11 & EU Annexure 11 compliance.
24. Core Labelling Journey in Pharmaceutical Industry
- A core label (CDS-Core Data Sheet) is an internal Regulatory document which serves as the company’s global reference document for a product. It is used to communicate the company’s position to appropriate stakeholders worldwide for the inclusion of safety and efficacy information on country-specific labels. A Core label is either prepared before or after the Regulatory approval (or another Regulatory pathway), in order to market a medicinal product worldwide.
- This workshop will discuss the unique experience in the field of labelling, and Core labelling in particular, makes it an ideal resource for companies that create or revise CCDS and CCSI and harmonize local safety labelling.