Good Manufacturing Practice is that part of Quality Assurance which ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification. Good Manufacturing Practice ...

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 following way: 1. Review documents 2. Prepare audit plan 3. Key persons 4. Audit responsibilities 5. Internal ...

Maintenance of sterile areas is an important task because air, as well as personnel working in sterile classified areas, are major sources of contamination. Below are some good manufacturing practice points that will help maintain a sterile environment. 1. Precautions should be taken to minimize contamination ...

Good Manufacturing Practice (GMP) is a set of standards that a manufacturer must meet to produce a safe and effective product. The most common GMP for pharmaceuticals is cGMP, which covers aspects such as process validation, quality control and documentation. Pharmaceutical manufacturers must meet all ...

Maintenance of sterile areas is an important task because air, as well as personnel working in sterile classified areas, are major sources of contamination. Below are some good manufacturing practice points that will help maintain a sterile environment. 1. Precautions should be taken to minimize contamination ...

1. Incorrect entries in GMP records should not be overwritten or blocked to make it unreadable. Always use a single strike outline (For example Incorrect Entry) to mark the incorrect entry in such a manner that entry remains readable. 2. Correct entry should be written near to the strikeout entry. Person ...

1. Entries in the GMP records should be done contemporaneously with the activity. However, the procedure mentioned below should be followed in the exceptional case of missing entry in GMP records. 2. Missing entry in the GMP records can be re-entered later if the data are retrievable. (For example start ...

Cancellation of GMP records should only be allowed in the rare case with the approval of QA and in exceptional cases such as spillage of chemical on the record. Event investigation procedure should be followed to determine further course of action. The reason for cancellation should be documented for ...

GMP is a part of QA that ensures that products are consistently produced and controlled to quality standards appropriate for their intended use and as required by marketing authorization or product specifications. GMP aims primarily to reduce the risks inherent in any pharmaceutical production. The basic ...

Good Manufacturing Practices (GMP) are a set of standards that pharmaceutical companies must adhere to in order to make safe and effective medicines. GMP requirements are based on the principles of quality, safety and efficacy. The most important aspect of GMP is quality. Pharmaceutical products must ...