Good Manufacturing Practices (GMP) Lesson 3 PDF

GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS Lesson #3 GOOD MANUFCTURING Associate Prof. Sami Mohamed BUC, School of Biotechnology  CONTENTS GMP in manufacturing processes QA, GMP and QC definition and comparison 5Ps Organization and...

GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS Lesson #3 GOOD MANUFCTURING Associate Prof. Sami Mohamed BUC, School of Biotechnology  CONTENTS GMP in manufacturing processes QA, GMP and QC definition and comparison 5Ps Organization and personnel Building and facilities Equipment Current GMP Ten Principles of GMP Production and process control products The inspection for compliance with GMP regulations  What is GMP? (Good Manufacturing Practices) GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufacture will have the required quality.  Good Manufacturing Practices A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.  5Ps Main Components of Good Manufacturing Practice 1. People - All employees are expected to strictly follow manufacturing processes and regulations. A GMP training must be undertaken by all employees to fully understand their roles and responsibilities. Assessing their performance helps boost their productivity, efficiency, and competency. 2. Products - All products must undergo constant testing, comparison, and quality assurance before distributing to consumers. Manufacturers should ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products. 3. Processes - Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization. 4. Procedures- A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be laid out to all employees and followed consistently. Any deviation from the standard procedure should be reported immediately and investigated. 5. Premises - Premises should promote cleanliness at all times to avoid cross-contamination, accidents, or even fatalities. All equipment should be placed or stored properly and calibrated regularly to ensure they are fit for the purpose of results to prevent the risk of equipment failure.  Why GMP is important Poor quality medicine may contain toxic substances that have been non-observed added. A medicine that contains little or none of the ingredient will not have the intended therapeutic effect.  GMP QA GMP QC QA: Quality Assurance GMP: Good Manufacturing Practices QC: Quality Control QA, GMP & QC inter-relationship QA It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use  GMP GMP Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use  QA, GMP & QC inter-relationship QC Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality  QC and QA QC is that part of GMP QA is the sum total of which is concerned with organized arrangements sampling, specifications, made with the object of testing and with in the organization, documentation ensuring that product and release procedures which will be of the Quality ensure that the necessary and required by their relevant tests are carried out intended use.  QC and QA Operational laboratory All those planned or techniques and activities systematic actions used to fulfill the necessary to provide requirement of Quality adequate confidence that a product will satisfy the requirements for quality  QC and QA QC is lab based QA is company based  Validation Definition Documented evidence that provides a high degree of assurance that a specific process, facility, or support system will consistently produce a product meeting its predetermined specifications and quality attributes. Validation helps assure that: Products are pure, safe and effective  Ten Principles of GMP Create Standard Operating Procedures (SOP) for processes and design specifications for facilities and equipment Follow the SOP and specifications Validate the SOP and specifications Document everything Monitor the facilities and equipment Employ competent and qualified personnel Protect products against contamination Control components and processes that are related to the product Ensure quality in operations, manufacturing, logistics, and distribution Perform periodic audits with certified auditors 16  List of important documents in GMP Policies SOP (Standard Operating Procedure( Specifications MFR (Master Formula Record( BMR (Batch Manufacturing Record( Manuals Master plans/ files Validation protocols Forms and Formats Records  What are cGMPs ? cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA( cGMP provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations  Why are cGMP so important A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While cGMPs require testing ,single testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 1000 tablets from a batch that contains 2 million tablets), so that most of the batch have to be tested.  Building and facilities 1. Design and construction features. 2. Lighting. 3. Ventilation, air filtration, air heating and cooling. 4. Plumbing. 5. Sewage and refuse. 6. Washing and toilet facilities. 7. Sanitation. 8. Maintenance.  Equipment 1. Equipment design, size, and location. 2. Equipment construction. 3. Equipment cleaning and maintenance. 4. Equipment calibration 5. Automatic, mechanical, and electronic equipment. 6. Filters. 7. Filing each document by date  Production and process control 1. Written procedures; deviations. 2. Charge-in of components. 3. Calculation of yield. 4. Equipment identification. 5. Sampling and testing of in-process materials and drug products. 6. Time limitations on production. 7. Control of microbiological contamination. 8. Reprocessing.