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Bp 606 t lecture 2

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D2 SIR

1. The document discusses the key differences between quality assurance (QA) and quality control (QC). QA focuses on processes and aims to prevent defects, while QC focuses on products and aims to identify defects. 2. It also provides an overview of Good Manufacturing Practices (GMP), which ensure products are consistently produced according to quality standards. GMP covers all aspects of production from materials to equipment to personnel. 3. The main GMP principles are that manufacturing processes are clearly defined and validated, adequate resources are provided, instructions are written clearly, procedures are followed correctly, and comprehensive records are kept.

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Unit 1: Lecture 2: Quality Assurance and Quality Management concepts: Differences between Quality control & Quality assurance and GMP By D2 Sir
Disclaimer: All the content material provided here is only for teaching purpose.
DIFFERENCE BETWEEN QAAND QC 1. QA is process oriented and QC is product oriented. 2. QA is a set of activities for ensuring quality in the processes by which products are developed QC is a set of activities for ensuring quality in the products. 3. The activities focus on identifying defects in the actual products produced. 4. QA is a managerial tool while QC is a corrective tool.
5. QA aims to prevent defects with a focus on the process used to make the product while QC aims to identify and correct defects in the finished products. 6. QA goal of QA is to improve development and test processes so that defects do not arise when the product is being developed while Goal of QC is to identify defects after a product is developed and before its released. 7. QA aim is to prevent the defect. While QC aim is to identify and improve the defects. 8. QA is the technique of managing the quality. While QC is method to verify the quality.
9. QA does not involve executing the program. While QC always involves executing the program. 10. All team members are responsible for QA. While Testing team is responsible for QC. QA e.g. Verification. While QC e.g. Validation. 11. QA means Planning for doing a process. QC Means Action for executing the planned process. 12. Statistical Technique used on QA is known as Statistical Process Control (SPC.)
Statistical Technique used on QC is known as Statistical Quality Control (SPC.) 1. QA makes sure you are doing the right things. QC makes sure the results of what youve done are what you expected. 2. QA Defines standards and methodologies to followed in order to meet the customer requirements. QC ensures that the standards are followed while working on the product. 3. QA is the process to create the deliverables. QC is the process to verify that deliverables. 4. QA is responsible for full software development life cycle. QC is responsible for software testing life cycle.
GOOD MANUFACTURING PRACTICE (GMP): Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use. GMP A set of principles and procedures which, when followed by manufacturers for the therapeutic goods, helps ensure that the products manufactured will have the required quality It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP COVERS: All aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documents proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made.
WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.
UNDER THE GMP: 1.All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications. 2.Qualification and validation are performed. 3.All necessary resources are provided, including: sufficient and appropriately qualified and trained personnel, adequate premises and space, suitable equipment and services, appropriate materials, containers and labels, approved procedures and instructions, suitable storage and transport, adequate personnel, laboratories and equipment for in- process controls;
4. Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided. 5. Procedures are carried out correctly and personnel are trained to do so. 6. Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented.
7. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form. 8. The proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices (GDP). 9. A system is available to recall any batch of product from sale or supply. 10. Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence.
LISTS OF IMPORTANT DOCUMENTS IN GMP Policies, Standard operating procedures SOP, Specifications, Master formula records MFR, Batch manufacturing record BMR, Manuals, Master plans/Files, Validation protocols, Forms and formats, Records.
References: https://www.ramauniversity.ac.in/online-study- material/pharmacy/bpharma/visemester/pharmaceuticalqualityassurance/lecture-1.pdf
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Bp 606 t lecture 2

  • 1. Unit 1: Lecture 2: Quality Assurance and Quality Management concepts: Differences between Quality control & Quality assurance and GMP By D2 Sir
  • 2. Disclaimer: All the content material provided here is only for teaching purpose.
  • 3. DIFFERENCE BETWEEN QAAND QC 1. QA is process oriented and QC is product oriented. 2. QA is a set of activities for ensuring quality in the processes by which products are developed QC is a set of activities for ensuring quality in the products. 3. The activities focus on identifying defects in the actual products produced. 4. QA is a managerial tool while QC is a corrective tool.
  • 4. 5. QA aims to prevent defects with a focus on the process used to make the product while QC aims to identify and correct defects in the finished products. 6. QA goal of QA is to improve development and test processes so that defects do not arise when the product is being developed while Goal of QC is to identify defects after a product is developed and before its released. 7. QA aim is to prevent the defect. While QC aim is to identify and improve the defects. 8. QA is the technique of managing the quality. While QC is method to verify the quality.
  • 5. 9. QA does not involve executing the program. While QC always involves executing the program. 10. All team members are responsible for QA. While Testing team is responsible for QC. QA e.g. Verification. While QC e.g. Validation. 11. QA means Planning for doing a process. QC Means Action for executing the planned process. 12. Statistical Technique used on QA is known as Statistical Process Control (SPC.)
  • 6. Statistical Technique used on QC is known as Statistical Quality Control (SPC.) 1. QA makes sure you are doing the right things. QC makes sure the results of what youve done are what you expected. 2. QA Defines standards and methodologies to followed in order to meet the customer requirements. QC ensures that the standards are followed while working on the product. 3. QA is the process to create the deliverables. QC is the process to verify that deliverables. 4. QA is responsible for full software development life cycle. QC is responsible for software testing life cycle.
  • 7. GOOD MANUFACTURING PRACTICE (GMP): Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use. GMP A set of principles and procedures which, when followed by manufacturers for the therapeutic goods, helps ensure that the products manufactured will have the required quality It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
  • 8. GMP COVERS: All aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documents proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made.
  • 9. WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.
  • 10. UNDER THE GMP: 1.All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications. 2.Qualification and validation are performed. 3.All necessary resources are provided, including: sufficient and appropriately qualified and trained personnel, adequate premises and space, suitable equipment and services, appropriate materials, containers and labels, approved procedures and instructions, suitable storage and transport, adequate personnel, laboratories and equipment for in- process controls;
  • 11. 4. Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided. 5. Procedures are carried out correctly and personnel are trained to do so. 6. Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented.
  • 12. 7. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form. 8. The proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices (GDP). 9. A system is available to recall any batch of product from sale or supply. 10. Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence.
  • 13. LISTS OF IMPORTANT DOCUMENTS IN GMP Policies, Standard operating procedures SOP, Specifications, Master formula records MFR, Batch manufacturing record BMR, Manuals, Master plans/Files, Validation protocols, Forms and formats, Records.