Consistent production and quality control are at the heart of the GOOD MANUFACTURING PRACTICE (GMP) idea. Its goal is to keep patients as safe as possible throughout the manufacturing process of any medicine. MP comprises the permission to operate in pharmaceutical manufacture, and is a key criterion globally. It’s important to keep in mind that laws and interpretations vary greatly from nation to country.
All guidelines follow a few basic principles:
- The manufacture and distribution of the pharmaceuticals must minimize any danger to their quality.
- Production facilities must maintain a clean and sanitary manufacturing space, including labs and storage.
- For the safety of pharmaceutical goods, the design, operation, and atmosphere of manufacturing facilities must be strictly regulated to avoid cross-contamination between marked and unlabeled materials or products.
- Manufacturing processes must be thoroughly defined, verified and regulated to guarantee consistency and conformity with standards. Any modifications to the process are examined from a patient safety and product quality viewpoint, and any authorized change that may influence the quality of the medicine are qualified or validated as appropriate.
- Clear and unambiguous language is required in the writing of instructions and processes (Good Documentation Practices).
- Operators should be taught to carry out the manufacture and control of goods according to documented and authorized processes.
- Documentation should be kept throughout production and quality control to show that all actions necessitated by the stated processes and instructions have been carried out correctly and that all quality characteristics specified for the goods have been satisfied. The investigation and documentation of deviations are standard operating procedures.
- Throughout the product’s lifespan, the procedure should be kept under tight supervision and tweaked as necessary.
- Records of manufacturing (including distribution) are preserved in an intelligible and accessible format that may track the whole history of a batch.
- Any batch that has been sold or supplied must be able to be recalled via some mechanism.
- Complaints concerning marketed goods should be reviewed, the sources of quality problems probed, and necessary steps made with regards to the faulty items and to avoid recurrence.
GMP guidelines are not prescriptive rules on how to make items. To be successful in the manufacturing process, a set of general rules must be followed. When a firm is putting up its pharmaceutical quality system, manufacturing processes and control, there may be several approaches to achieve GMP criteria. It is the company’s job to select the most effective and efficient quality method.
