Current good manufacturing practices(cGMP)

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CURRENT GOOD MANUFACTURING PRACTICES (cGMP):

CURRENT GOOD MANUFACTURING PRACTICES (cGMP) By Dr. Ramanjireddy Tatiparthi JIMMA UNIVERSITY

What is GMP ?:

What is GMP ? GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the desired Quality standards appropriate for intended use "GMP" - A set of principles and procedures which, followed by manufacturers for therapeutic goods, helps ensure that the products manufactured the required quality.

GMP guidelines:

GMP guidelines GMP as per Schedule “M” www.cdsco.nic.in GMP as per WHO www.who.int GMP as per MCA now known as MHRA www.mca.gov.uk GMP as per TGA www.tga.gov.au GMP as per US FDA www.fda.gov GMP as per ICH guidelines www.ich.org

Organization & Personnel:

Organization & Personnel Responsibilities of quality control unit. The authority to review production records to assure that no errors Responsible for approving or rejecting drug products manufactured, processed, packed. 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. Personnel qualifications. Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience to enable that person to perform the assigned functions. Training in current good manufacturing practice shall be conducted by qualified individuals. Assure that employees remain familiar with CGMP requirements Each person responsible for supervising safety, identity, strength, quality, and purity

Organization & Personnel:

Organization & Personnel 3. Personnel responsibilities . Personnel engaged in the operation of holding a drug product shall wear clean clothing for duties. Protective apparel, such as head, face, hand, and arm coverings , shall be worn as necessary to protect drug products from contamination. Any person shown at any time to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products 4. Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, to advise on the subject for which they are retained.

Building & Facilities:

Building & Facilities Design and construction features. Any building used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance. The orderly placement of equipment and materials to prevent mix-ups between different components , drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. 2. Lighting. Adequate lighting shall be provided in all areas.

Building & Facilities:

Building & Facilities 3. Ventilation, air filtration, air heating and cooling. Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product. Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. there shall be adequate exhaust systems or other systems adequate to control contaminants. 4. Plumbing. Potable water shall be supplied under continuous positive pressure in a plumbing system. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break to prevent back siphonage . 5. Sewage and refuse. Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner.

Building & Facilities:

Building & Facilities 6. Washing and toilet facilities. Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas. 7. Sanitation. Building shall be free of infestation by rodents, birds, insects, and other vermin. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. 8. Maintenance. Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.

Production & Process Control:

Production & Process Control Written procedures and deviations. There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity Any deviation from the written procedures shall be recorded and justified. 2. Charge-in of components. The batch shall be formulated with the intent to provide not less than 100 percent of the labeled amount of active ingredient. Component name or item code; Receiving or control number; Weight or measure in new container; Batch for which component was dispensed, including its product name, strength, and lot number.

Production & Process Control:

Production & Process Control 3. Calculation of yield. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. 4. Equipment identification. Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product.

Production & Process Control:

Production & Process Control 5. Sampling and testing of in-process materials and drug products. To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch Examination and testing of samples shall assure that the drug product and in-process material conform to specifications. Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing 6.Time limitations on production. Time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.

Production & Process Control:

Production & Process Control 7. Control of microbiological contamination. Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. 8. Reprocessing. Reprocessing shall not be performed without the review and approval of the quality control unit.

Packaging & Labeling Control:

Packaging & Labeling Control Materials examination and usage criteria. Records shall be maintained for each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected. Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations. 2. Labeling issuance. Strict control shall be exercised over labeling issued for use in drug product labeling operations. Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records. 3. Packaging and labeling operations. Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record.

Packaging & Labeling Control:

Packaging & Labeling Control 4. Tamper-evident packaging requirements An OTC drug product for retail sale, that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both. Package the product in a tamper-evident package, visible evidence to consumers that tampering has occurred. 5. Drug product inspection. Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling. Results of these examinations shall be recorded in the batch production or control records.

Packaging & Labeling Control:

Packaging & Labeling Control 6. Expiration dating. To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing. If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products . Expiration dates shall appear on labeling in accordance with the requirements.

Handling & Distribution :

Handling & Distribution Warehousing procedures. Written procedures describing the warehousing of drug products shall be established and followed. They shall include: Quarantine of drug products before release by the quality control unit. Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.

PowerPoint Presentation:

2. Distribution procedures. Written procedures shall be established, and followed, describing the distribution of drug products. They shall include: A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

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