Good Manufacturing Practice

We pride ourselves on implementing Good Manufacturing Practice standards for all of our products but what does that mean in terms of quality and how does it benefit you and your patients?

Good Manufacturing Practice 

Good Manufacturing Practice (GMP) is a system for ensuring that products consistently produce and control according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing.

Good manufacturing practice guidelines regulate the manufacturing, testing, and quality assurance to ensure that a manufactured product is safe for human consumption or use. Many countries now have to ensure that manufacturers follow GMP procedures and ensure their GMP guidelines correspond with legislation.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, every time a product is made.

All guideline follows a few basic principles:

• Manufacturing facilities must maintain a clean and hygienic manufacturing area.

• Manufacturing facilities must maintain controlled environmental conditions to prevent cross-contamination.

• Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

• Manufacturing processes must be controlled, and any changes to the process must be evaluated.

• Operators must be trained to carry out and document procedures.

• Records must be made, manually or electronically, during manufacture that demonstrates that all the steps required by the defined procedures and instructions were taken and that the quantity and quality of the food or drug were as expected. Deviations must be investigated and documented.

• Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.

• Any distribution of products must minimize any risk to their quality.

• A system must be in place for recalling any batch from sale or supply.

• Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken concerning the defective products and to prevent a recurrence.

We are committed to sourcing only products from GMP and GAP certified manufacturers, so we are proud to only work with GMP and GAP manufacturers so practitioners and patients can rest assured that Phoenix products are of the highest quality and safety.

If you have any further questions regarding GMP or the quality of our products, please contact info@phoenixmedical.com