Current good manufacturing practices and current good compounding
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The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It covers cGMP requirements for facilities, equipment, components, production processes, packaging, labeling, quality control, audits and more. The regulations aim to help manufacturers produce safe and effective pharmaceuticals for patients.
Current good manufacturing practices and current good compounding
- 1. Current Good Manufacturing Practices and Current Good Compounding Practices
- 3. Regulations are established by the Food and Drug Administration (FDA) to ensure that minimum standards are met for drug product quality in the United States OR What are cGMPs Rules set up by the FDA that drug manufacturers needs to follow in order to ensure that a safe and effective product is manufactured
- 4. cGMP Code of Federal Regulations (CFR) Finished Pharmaceuticals Biologic products Medicated articles Medical devices
- 5. GMP
- 6. GMP
- 7. GMP
- 8. PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
- 9. The GMP Institute was established Ten Principles of cGMP Principle1: Writing detailed step-by-step procedures that provide a roadmap for controlled and consistent performance Principle2 :Carefully following written procedures to prevent contamination, mix-ups and errors Importance of Written Procedures Procedures should be Clear , Concise and Logical Importance of Written Procedures Taking shortcuts may save time or make the task easier, but you should never deviate from a written procedure without the approval of a supervisor or Quality Department
- 10. The GMP Institute has established Ten Principles of cGMP Principle3 : Promptly and accurately documenting work for compliance and traceability Principle 4 : Proving that systems do what they are designed to do by validating Validate and Document Work To prove that our equipment and process consistently do what they are supposed to do
- 11. The GMP Institute has established Ten Principles of cGMP Principle 5 : Develop a good design for the facility and the equipment from the beginning Principle 6 : Properly maintaining facilities and equipment Design , construction and maintenance of the facility and equipment A Logical and well planning layout will improve productivity. Remove unnecessary traffic in the production area Segregate materials , products, and their components to minimize the confusion and potential mix-ups and errors It is important to control : Air, Water, Lighting, Ventilation, Temperature and RH
- 12. The GMP Institute has established Ten Principles of cGMP Principle7 : Clearly defining, developing and demonstrating job competence GMP makes for Competent Employees Training: include basic training on the theory and practice of GMP as well as specific training relative to their role Companies need people who know to do the job right the first time , every time
- 13. The GMP Institute has established Ten Principles of cGMP Principle 8 : Protecting products against contamination by making cleanliness a continual habit Practice good Hygiene •Health examinations •Written proceduresand instructions - to wash hands before entering production areas •Direct contact between product, raw materials and operator Should be avoided •Protection of product from contamination: Clean clothes appropriate to personnel activities Including hair covering (e.g. caps) •Check change rooms/changing facilities •Smoking, eating and drinking not allowed in production areas, laboratories and storage areas •No chewing (e.g. gum), or keeping food or drinks allowed •No plants kept inside these areas •Rest and refreshment areas should be separate from manufacturing and
- 14. The GMP Institute has established Ten Principles of cGMP Principle 9: Building quality into products by. . Systematically controlling our components and products Systematically controlling manufacturing processes packaging and labeling control Holding and distribution control
- 15. The GMP Institute has established Ten Principles of cGMP Principle 10 : Conducting planned and periodic audits for compliance and performance.
- 16. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Subpart A--General Provisions • Subpart B--Organization and Personnel • Subpart C--Buildings and Facilities • Subpart D—Equipment • Subpart E--Control of Components and Drug Product Containers and Closures • Subpart F--Production and Process Controls
- 17. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Subpart G--Packaging and Labeling Control • Subpart H--Holding and Distribution • Subpart I--Laboratory Controls • Subpart J--Records and Reports • Subpart K--Returned and Salvaged Drug Products
- 18. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Active ingredient or active pharmaceutical ingredient (API): Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body of man or other animals.
- 19. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Batch: A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture
- 20. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Lot: A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number. • Lot number, control number, or batch number: Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.
- 21. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Certification: Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable. • Compliance: Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices.
- 22. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Component: Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product. • Inactive ingredient: Any component other than the active ingredients in a drug product • Drug product: A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo.
- 23. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Master record: Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product
- 24. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Quality assurance: Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately. • Quality audit: A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.
- 25. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Quality control: The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference. • Quality control unit: An organizational element designated by a firm to be responsible for the duties relating to quality control
- 26. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Quarantine: An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use.
- 27. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS • Reprocessing: The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process. • Strength: The concentration of the drug substance per unit dose or volume
- 28. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals Subpart A--General Provisions
- 29. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart B--Organization and Personnel - Responsibilities of quality control unit. - Personnel qualifications. - Personnel responsibilities. - Consultants.
- 30. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart B--Organization and Personnel - Responsibilities of quality control unit. (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. (c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
- 31. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart B--Organization and Personnel - Personnel qualifications. (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
- 32. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart B--Organization and Personnel - Personnel responsibilities. (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.
- 33. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart B--Organization and Personnel - Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained
- 34. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart C--Buildings and Facilities - Design and construction features. Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. shall have adequate space - Lighting. - Ventilation, air filtration, air heating and cooling. - Plumbing. - Sewage and refuse. - Washing and toilet facilities. - Sanitation. - Maintenance.
- 35. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart D—Equipment - Equipment design, size, and location. - Equipment construction. Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product -Equipment cleaning and maintenance. Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product - Automatic, mechanical, and electronic equipment. - Filters. Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products.
- 36. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart E--Control of Components and Drug - Receipt and storage of untested components, drug product containers, and closures. - Testing and approval or rejection of components, drug product containers, and closures. - Use of approved components, drug product containers, and closures. - Retesting of approved components, drug product containers, and closures. - Rejected components, drug product containers, and closures. - Drug product containers and closures. The component is assigned a control number that identifies both the component and the intended product.
- 37. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart F--Production and Process Controls - Written procedures; deviations. - Charge-in of components. - Calculation of yield. - Equipment identification. - Sampling and testing of in-process materials and drug products. - Time limitations on production. - Control of microbiological contamination. - Reprocessing.
- 38. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart G--Packaging and Labeling Control - Materials examination and usage criteria. - Labeling issuance. - Packaging and labeling operations. - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. - Drug product inspection. - Expiration dating.
- 40. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart H--Holding and Distribution - Warehousing procedures. - Distribution procedures.
- 41. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart I--Laboratory Controls - General requirements. - Testing and release for distribution. - Stability testing. - Special testing requirements. - Reserve samples. - Laboratory animals. - Penicillin contamination.
- 42. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart J--Records and Reports - General requirements. - Equipment cleaning and use log. - Component, drug product container, closure, and labeling records. - Master production and control records. - Batch production and control records. - Production record review. - Laboratory records. - Distribution records. - Complaint files.
- 43. Complete master production and control records for each batch must be kept and must include the following: • Name and strength of the product • Dosage form • Quantitative amounts of components and dosage units • Complete manufacturing and control procedures • Specifications • Special notations • Equipment used • In-process controls • Sampling and laboratory methods and assay results • Calibration of instruments • Distribution records • Dated and employee-identified records
- 44. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart K--Returned and Salvaged Drug Products - Returned drug products. - Drug product salvaging.
- 46. QUALITY RELATIONSHIP Quality Management Quality Assurance G.M.P. Quality Control QC GMP QA
- 47. ACTIVE PHARMACEUTICAL INGREDIENTS AND PHARMACEUTICAL EXCIPIENTS • Specifications and analytical methods for all reactive and nonreactive components used in synthesis • Critical chemical reaction steps • Handling of chemical intermediates • Effect of scale-up of chemical batches on the yield • Quality of the water systems • Solvent handling and recovery systems • Analytical methods to detect impurities or chemical residues and the limits set • Stability studies of the bulk pharmaceutical chemical
- 48. CLINICAL TRIAL MATERIALS • The API used in a clinical investigation is subject to all of the requirements for the production of bulk pharmaceutical chemicals identity, purity, strength, and quality
- 49. CURRENT GOOD COMPOUNDING PRACTICES 1. Many patients need drug dosages or strengths that are not commercially available. 2. Many patients need dosage forms, such as suppositories, oral liquids, or topicals that are not commercially available 3. Many patients are allergic to excipients in commercially available products 4. Some medications are not very stable and require preparation and dispensing every few days; they are not suitable to be manufactured products.
- 50. CURRENT GOOD COMPOUNDING PRACTICES 6. Many drugs are reported in the literature but are not manufactured yet, so pharmacists can compound them for their physicians’ and patients’ use 7. Many physicians desire to deliver products in innovative ways, and pharmacists can work with them to solve medication problems 8. Most products are not available for veterinary patients and must be compounded
- 51. CURRENT GOOD COMPOUNDING PRACTICES 9. Home health care and the treatment of an increasing number of patients at home have resulted in many community pharmacies and home health care pharmacies preparing sterile products for home use; formerly, most sterile products were compounded in hospital pharmacies. .
- 52. PRESCRIPTION LABEL • The name and address of the pharmacy • The serial number of the prescription • The date of the prescription or the date of its filling or refilling (state law often determines which date is to be used) • The name of the prescriber • The name of the patient • Directions for use, including any precautions, as indicated on the prescription
- 53. PRESCRIPTION LABEL • The address of the patient • The initials or name of the dispensing pharmacist • The telephone number of the pharmacy • The drug name, strength, and manufacturer’s lot or control number • The expiration date of the drug • The name of the manufacturer or distributor In addition, state laws may require additional information: