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Currently, the FDA is the only national authority tasked with enforcing and issuing policies on cGMPs. As a rule, a drug is considered adulterated if the facility used to manufacture it and the packaging and processing do not conform to cGMPs. So during inspection, CGMP regulations ensure product safety, functionality and quality first.
The FDA decides whether firms are complying with cGMPs by inspecting the firm’s facilities, analyzing samples, and examining compliance history. Products that do not meet stated objectives during processing and packaging or lack of quality control predispose a firm to regulatory action by the FDA. Therefore, manufacturers must be aware of the burden of full responsibility for acquiring knowledge.
cGMPs also provide that an individual may only comply with regulations that govern the specific activities they engage in Additionally, these regulations require that a manufacturer not only be compliant but also maintain timely attention to innovations in the industry. The new regulation must be implemented immediately. Firms have a major responsibility to ensure that adequate education and training is provided to their staff on the cGMP requirements applicable to them.
cGMPs serve as the basis for evaluating whether pharmaceuticals are safe and effective for human use. In addition, they are the main quality regulations that drug manufacturing companies are expected to adhere to. According to cGMP guidelines if a pharmaceutical product passes all the specified tests produced in GMP that violates the manufacturing conditions it should not reach the market.
The following are basic GMP facility requirements that pharmaceutical manufacturers must follow:
• Manufacturing process should be properly defined and controlled. All critical processes should be verified to ensure process continuity. Process validation results should conform to specifications.
• Batch manufacturing records should be controlled, and any changes to the process should be evaluated. Any changes that may affect product quality must be verified.
• Procedures and any instructions should be written in clear language for proper understanding.
• Personnel should be trained to carry out production, quality control and documentation.
• During the production and testing of final products, records are created manually or by machines that provide evidence that all the steps defined in the procedures and instructions have been carried out correctly. Any deviation from written procedures should be investigated and documented.
• Production documents including distribution along with a complete history of a batch should be retained until the expiry of the batch.
• A well-defined procedure should be available to withdraw any batch from the market.
• Batches should check market complaints and investigate root causes of defects and take appropriate preventive measures to prevent recurrence of defects.
