TopicEverything you should know about GMP Certification
What is GMP Certification?
Good Manufacturing Practice (GMP) is regularity for ensuring that products are consistently manufactured and controlled according to quality standards. It is designed to reduce the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP Certificate covers all aspects of production from the starting materials, premises, and equipment to the training and personal cleanliness of staff. Comprehensive written procedures are essential for each process that could affect the quality of the finished product. It should be practiced here to provide documented evidence that the correct procedures are consistently followed at every step in the manufacturing process - whenever a product is made.
What are the benefits of having GMP Certification?
- Promotes brand value or image in the market
- Give guidelines on how to produce safe and quality products.
- Strengthens customer satisfaction by delivering safe and quality products and services.
- Increases motivation and teamwork between the employees of the organization.
What are the Guidelines for the GMP Certifications?
- Hygiene: Pharmaceutical manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions to prevent cross-contamination of foods or food products that execute a product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All crucial processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are assessed. Changes that have an impact on the quality of the drug are verified as necessary.
- Instructions and procedures are clearly written.
- Administrators are trained to carry out and document procedures.
- The records are made physically or by hardware during produce, which suggests that all the means required by characterized techniques and directions were really taken and the amount and nature of food or medication anticipated. Deviations are audited and reported. The conveyance of the food or medications limits any hazard to their quality.
- Records of manufacture that facilitate the complete history of a batch to be traced are retained in an understandable and accessible form.
- A conveyance of the food or medications limits any hazard to their quality
- A system is available for reviving any batch from sale or supply.
- Complaints about sold products are investigated, the causes of quality checks are reviewed, and relevant measures are taken with respect to the defective products and to prevent a recurrence.