GMP audit is a process by which an external or internal individual or team verifies that a manufacturer is following its documented Good Manufacturing Practices. GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations for the audit ...

1. Introduction: Self-inspection is essentially a method of objective overall review of one’s operation on aspects that may have a quality impact on quality assurance. In general, self-inspection aims to identify defects that are critical, major or minor in nature. Self-inspection should be carried ...

1. The premises are cleaned & situated in an environment which has minimum risk for contamination. 2. Sufficient area for storage of unwashed clothes & washed clothes. 3. Washing & drying premises was found cleaned & in good condition. 4. There are arrangements to control the entry ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in the following ways: 1. Documents reviewed: A list of all documents related to the audit should be prepared. ...

Implementing an effective internal audit system in pharmaceuticals can be challenging, but there are some key tips that can help. First, it is important to ensure that all employees are aware of the importance of complying with internal audit procedures. Second, it is crucial to have a dedicated team ...

FDA inspections are an important part of ensuring the safety and efficacy of products that come into contact with the public. The FDA tests products to ensure they are safe, effective and meet all label requirements. When you receive notification from the FDA that your product has been recalled, the ...

1 Site Master File. 2 Air Quality Manuals. 3 Water Quality Manual. 4 All process-related SOPs. 5 Standard Testing Procedures (STPs) and Specifications for Raw Material, Packing Material, Intermediate, and Finished Product. 6 Market Complaints Record. 7 Calibration Record. 8 Process Validations report ...

Internal audit is an important part of ensuring the safety and quality of pharmaceuticals. Here are some tips for creating an effective internal audit system in pharmaceuticals: 1. Establish clear objectives for internal audit. It is important for internal audits to have clear goals so that everyone ...

Internal audit is an important part of ensuring the safety and quality of pharmaceuticals. Here are some tips for creating an effective internal audit system in pharmaceuticals: 1. Establish clear objectives for internal audit. It is important for internal audits to have clear objectives so that everyone ...