Good Manufacturing Practices (GMP) is a system to ensure that the product manufactured is produced consistently with high quality standards.
GMP is designed to reduce the risk involved in the manufacturing of pharmaceutical products. GMP specifically addresses the risk of contamination, cross-contamination, and mix-ups of drugs that can not be controlled by testing the product.
To meet the expectations of the regulatory agency some basic principles of GMP need to follow by the industry.
10 Basic Principles of Current Good Manufacturing Practices (cGMP):
- Standard Operating Procedures (SOP):
- Follow written procedures (SOP, guidance documents)
- Documentation of work (On time and online)
- Validate the work
- Design facility and equipment
- Competency of employee
- Personnel and hygiene
- Quality control or Quality By Design (QBD)
- Audits and compliance
Let’s understand all principles,
1. Standard Operating Procedure (SOP):
The first principle of GMP is the standard operating procedure. SOP is a set of tests and a step-by-step guide for performing analysis and product manufacturing inconsistent manner. The SOP includes a set of instructions, procedures, calculations, and the suitability of instruments.
2. Follow the written procedure:
To get high quality and consistent results the procedure mentioned in the sop needs to be followed. No shortcuts and deviations from the procedure are allowed. Shortcuts and deviations of procedure produce wrong results that may show variation in results.
3. Documentation of work:
Documentation of work is an important part of GMP. Documentation is evidence of what work was performed. Documentation of work is useful for future reference. If any problem persists in the future with the product, documentation will help to investigate the proper cause of the problem.
4. Validate the work:
The system and processes for written procedures and documentation are needed to validate to ensure that they are working properly.
5. Design facility and equipment:
The design of the facility plays an important role. The design of the facility in such a way that it fulfills product quality, employee safety, and regulatory requirements. The types of equipment used for manufacturing should be validated and qualified to produce consistent results.
Facility and equipment must be maintained with documented evidence of work done. To maintain records of backup of equipment. This avoids the potential issues of contamination and safety concerns as well.
7. Competency of employee:
The competency of employees must be checked and accordingly to assign job responsibilities is also important. Employee education, employee experience, and employee training is an important parts to get good output. Job responsibilities clearly demonstrate to the employee before starting the activity.
8. Personnel and hygiene:
The pharmaceutical industry produces life-saving drugs. The first step to achieving this is to make sure of cleanliness in the workplace. The contamination of drugs can be life-threatening. To avoid these proper standards should be in place. Proper hygiene practices should be in place to protect the drug from contamination, cross-contamination, and mix-ups.
9. Quality control or Quality by design:
Quality control is one of the most important principles of GMP. To check the quality and efficacy of a drug product Quality control plays an important role. The quality control checks major area such as API, packing material, in-process check parameters, and finish product. Quality control checks major quality attributes and releases the product with a quality certificate.
10. Audit and compliance:
The last principle is Audit and compliance. Ensuring compliance is in place the only way to do internal audits. Periodic audits can give assurance and determines the proper GMP implementation.
To get an assurance that the organizations are following current practices of the industry, the regulator has asked about following current good manufacturing practices (cGMP). The certified cGMP organization is having a good reputation.Important Note:
Compliance and proper implementation of current good manufacturing practices (cGMP) produce high-quality and consistent products that build the trust of the regulator or regulatory agency and ultimately business improvement also.