cGMP is an acronym of "current Good Manufacturing Practices.” It is an internationally recognized standard used in the manufacture of therapeutic goods. cGMP is designed to ensure that processes performed, equipment used, in-process testing and end process testing comply within the standards through proper traceable documentation and have the required quality. It also ensures that the manufacturing facility consistently provide a high level of assurance of the quality, safety, and efficacy of therapeutic goods.
GMP for Medicinal Products is administered in Malaysia by the National Pharmaceutical Control Bureau (NPCB) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guides.
Although there are a number of GMP guidelines, all of them follow a few basic principles:
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the product are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language.
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Deviations are investigated and documented.
- Records of manufacture that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- The distribution of the product minimizes any risk to their quality.
- A system is available for recalling any batch of product from sale or supply.
- Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective product and to prevent recurrence.
- At the end of this workshop, participant should able to:
- Explain why TEC has implemented GMP
- State the GMP requirements for personal hygiene
- Describe the correct ways to complete GMP records
- Describe the proper ways of managing critical materials
- Describe the proper ways of managing non-conformances
- Describe the proper ways of facility and equipment management
- Describe the proper ways of cleaning the classified areas
- Acquired knowledge in aseptic hand washing and hand decontamination
- Acquired knowledge in aseptic open donning
- Acquired knowledge in gowning for entering Grade B Area
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