Good manufacturing practices & standard operating procedure
- 1. GOOD MANUFACTURING PRACTICES & STANDARD OPERATING PROCEDURE Assurance of Quality Pharmaceuticals Products University of Development Alternative
- 2. OUTLINE › What is Good manufacturing practice? › THE BENEFITS OF GMPs › MAIN PRINCIPLES OF GMP › What is an S.O.P? › BENEFITS OF SOP › Features of A “GOOD” Standard Operating Procedure › TYPICAL STRUCTURE FOR SOPS
- 3. What is “GOOD MANUFACTURING PRACTICE”? Good Manufacturing Practices (GMP) are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization. Based on fundamental concepts of Quality Assurance Principles Control Quality, safety, and effectiveness must be designed and built into the product Quality cannot be inspected or tested into a finished product Each step of manufacturing must be controlled to maximize the chances that the Finished Good will be acceptable
- 4. WHAT ARE THE BENEFITS OF GMPs? › – They outline a Quality System that reduces or prevents errors › – Ensures products are safe for use in humans › – Prevent/control contamination and cross-contamination › – Minimizes variations in potency of the drug › – Ensures reproducible physiological activity › – Prevent side effects and toxicity due to variations in drug content and potency › – Prevents mislabeling and adulteration
- 5. MAIN KEY PRINCIPLES OF GMP › Organization and Personnel › Buildings and Facilities › Equipment › Control of Components and Drug Product Containers and Closures › Production and Process Controls › Packaging & Labeling Control › Holding & Distribution › Laboratory Controls › Records & Reports › Returned & Salvaged Drug Product
- 6. MAIN KEY PRINCIPLES OF GMP › Organization and Personnel – Management Responsibility Responsible for facility, quality system, organizational structure, ensuring adequate resources – Responsible for actions of those reporting to them – Responsible for reviewing products annually, and procedures routinely – Responsible for providing adequate resources to perform operations Facilities, personnel, training, equipment, etc.
- 7. MAIN KEY PRINCIPLES OF GMP › Buildings and Facilities – Buildings must be designed with adequate size and space for operations – Facilities must be validated There must be a good flow pattern for personnel, materials, products and waste materials. The facility must be easy to clean and sanitize – Environmental controls must be in place – Utilities must be validated (water systems, electrical, etc) › Equipment Equipment should be selected based on the intended use and clean ability if it is to be in a clean room Equipment must be placed in an appropriate location. Equipment must be properly qualified.
- 8. MAIN KEY PRINCIPLES OF GMP › Component/Materials Control Suppliers must be evaluated and approved and monitored for quality Incoming Materials must be tested before they can be accepted for use Materials must be placed in stores or issued according to FIFO (stock rotation) Materials must be stored so that they are not mixed up, damaged, or contaminated. › Production/Process Control Have & Follow Procedures: A good procedure is a written step-by-step procedure that provides a roadmap for Controlled and Consistent performance. Examples: › – (Manufacturing) Work Instructions › – Operating Procedures › – Testing Procedures › – Quality Manual Deviations must be recorded and justified
- 9. MAIN KEY PRINCIPLES OF GMP › Packaging and Labeling Control Label is a display of a written, printed or graphic matter upon the immediate container of any article Labeling is the label and any other packaging material or container that is printed (ex. IFU, advertising materials) Procedures must exist that document receiving, identity, storage, handling, sampling, and testing of labels and ensure that integrity is maintained throughout production and use of product › Holding and Distribution Warehousing procedures should address… …Quarantine of drug products …storage of products under appropriate conditions Distribution procedures should address… …FEFO (First Expiring First Out) …traceability of product lots/batches › Laboratory Controls Written procedures must be established & followed All actions must be documented at the time of performance
- 10. MAIN KEY PRINCIPLES OF GMP › Records and Reports Quality Records are the proof that the procedures were followed and they show traceability of product. › Quality Records – Records are legal documents and can be subpoenaed in a court of law as evidence – Signatures on documentation have the same meaning as on any kind of contract – Information must be recorded and signed for at the time of performance on the original record
- 11. What is an S.O.P?
- 12. What is “Standard Operating Procedure (SOP)” › A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization.
- 13. Features of A “GOOD” Standard Operating Procedure › Should provide all the information necessary to perform a task › Is usually specific to the equipment used for the procedure › Should be detailed › Should “Stand Alone” › Should provide Quality Control information › Should provide References
- 14. BENEFITS OF SOP › 1. To perform a job properly. › 2. To ensure that production operations are performed consistently. › 3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. › 4. To ensure that no failures occur in manufacturing and other processes for which the SOP was written. › 5. To ensure that approved procedures are followed in compliance with company and government regulations. Quality Assurance, Quality Square Industry.
- 15. BENEFITS OF SOP › 6. To serve as a training document for teaching users about the process. › 7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. › 8. To serve as a checklist for auditors. › 9. To serve as an historical record for the Change over. › 10.To serve as an explanation in review of accident investigations
- 16. TYPICAL STRUCTURE FOR SOPS 1. Title Page: This includes 1) the title of the procedure, 2) an SOP identification number, 3) date of issue or revision, 4) the name of the agency/division/branch the SOP applies to, and 5) the signatures of those who prepared and approved of the SOP. This can be formatted however you like, as long as the information is clear.
- 17. › Table of Contents: This is only necessary if SOP is quite long, allowing for ease of reference. A simple standard outline is what you'd find here. › Quality Assurance/Quality Control: A procedure is not a good procedure if it cannot be checked. Have the necessary materials and details provided so the reader can make sure they've obtained the desired results. This may or may not include other documents, like performance evaluation samples.
- 18. › Reference: Be sure to list all cited or significant references. If reference other SOPs, its important to attach the necessary information in the appendix.
- 19. Questions or Any Query ?
- 20. CONTACT Name: Ruhid Hasan ID: 031161009 Batch: 48th Pharmacy Dept.