Millions of drug products are shipped annually. There is ample risk in assuming that the drug manufacturer is producing drug in a controlled manner and possibility of any parcel unit of contaminated drug will be identified. To address these problems and ensure high quality of the drugs, a reliable GMP or Good Manufacturing Practices Audit is essential. It should be an integral part of your QA or Quality Assurance program.
What is a GMP Audit?
A GMP Audit is a third-party, comprehensive inspection of some manufacturing or production company. It is aimed at identifying GMP/legal violations and operational flaws. In addition to particular inspection results, GMP auditing services should communicate a specific set of guidelines and standards on meeting these standards.
Importance of GMP Audits for Every Business
As per a study report by the FDA (Drug & Drug Administration) US and its strategy for the safety of imported drug items, it is reported that the United States of America imports around 40 percent of its total medicine supply. The country imports drug from over 200 nations.
Recently in 2019, FDA revised its strategy by outlining a new approach to ensuring food and drug safety measures. It has been designed for meeting the ever-growing complexity of supply chains and global markets.
Important Parts of a Dedicated GMP Audit
The GMP Audit provider checklist as put forth by the FDA includes:
- Plant & grounds: Auditors will be assessing cleanliness of the surrounding lot, building functionality, storage units, proper ventilation, and light and glass bulb protection.
- Personnel: The GMP audit report spans the procedures of the suppliers for reporting dress codes of the employees, sickness, training methods, drug handling procedures, and supervision policies.
- Sanitary Operations: The thoroughness and frequency of equipment & facility cleaning along with storage practices of toxic substances, effectiveness of pest control, and disposal procedures of single-use paper.
- Processes and controls: Conducting quality control checks on all resources and raw materials –working areas for cross-contamination, microorganisms, drug packaging, allergen potential, and checks for shipping procedures.
- Warehousing and distribution: Proper storage and hauling procedures, records related to previously shipped loads by specific containers, safety labeling, and stock rotation.
- Defect Action Levels: Processes put in proper place for immediately addressing product defaults.
- Equipment and utensils: Proper cleaning as well as maintenance of corrosion-resistant materials, contours, and surfaces designed to prevent the stimulation of microorganism growth.
Risks Without Proper GMP Auditing and Inspections
It is not in the capacity of the FDA to inspect every medicinal product/unit manufactured and sold in the United States of America. The overall responsibility for maximizing safe and hygienic drug manufacturing processes should essentially fall on the business with help from reliable GMP audit pharmaceutical companies.
If you wish to catch up with your business, you should aim at stopping violations and contaminations related to drug processing. However, chances are contaminated drugs eventually will make their way to the end consumers. When you partner with accredited third-party supply chain GMP audit companies. you can change the overall culture of the supply chain while mitigating the risks effectively.