What are checklists for conducting a Pharma Audit?
The GMP guidelines (Good Manufacturing Practice) describe the quality assurance system for the production of medicinal products and active ingredients. These GMP guidelines are intended to prevent counterfeit medicines from reaching the consumer. On the other hand, Pharma Audits ensure the quality assurance of medical products.
Pharmaceutical audits lead to safe and qualitative auditing of the products. pharmaceutical audit checklists are also used for facilities and internal processes. Good Manufacturing Practice (GMP) is a fundamental element of quality assurance in the pharmaceutical industry and should be standardized and controlled with the greatest care. Checklists support the audit process and rationalize it.
The article deals with the following topics:
Pharma Audit – Requirement in medical technology
During the manufacturing process of medical products and active pharmaceutical ingredients, each individual step must be cleanly documented and trackable. It is important to note that third parties can also trace the manufacturing process. A pharma audit checklist for medical devices ensures that the individual steps are documented properly and in a standardised manner.
In order to bring an effective and safe medicinal product to the market, GMP regulations must be taken into account during the manufacturing process. All the people and areas involved are taken into account;
- Quality manager
In medical production, sterile and clean manufacturing is mandatory. Strict controls and guidelines are also essential. The requirements for the quality management system as well as the FDA – and the ISO standards play a central role in the GMP guidelines. Extensive monitoring of the immediate environmental conditions is just as much a part of medical manufacturing as the pure production of medical products.
3 benefits of a pharma audit checklist
All people involved in the manufacturing process must have the necessary knowledge of the regulations. This can be done in writing with a checklist. The three most important advantages of a GMP audit checklist are listed below
1. Meeting customer requirements
Quality management should aim to prevent errors and enable customers to obtain optimal quality medical products. Eliminating errors and weaknesses after the fact is expensive. By using checklists effectively, errors can be avoided by defining standardized controls in the GMP checklist.
2. Proactively prevent deviations
By using a pharma audit checklist, weaknesses and errors are proactively prevented. By evaluating and analyzing the final report, the possible causes of value deviations can be remedied directly. Technical failures of equipment can also be prevented by an intuitive tool. This prevents consequential damage from occurring in the first place.
3. Comply with legal regulations
Using digital checklists for regular GMP audits makes it easy to comply with legal requirements and regulations. The checklist questions and checks are directly in line with the regulations. This means that the completeness and quality requirements can be reliably met during the audits. The automatically generated final report is stored securely and can be forwarded directly to the responsible authority.
A digital solution for the pharma audit checklists
With Lumiform’s mobile app, you perform pharma audits according to regulatory requirements. The intuitive audit software allows you to reliably meet all regulatory requirements, from audit planning and assessment to high-quality reports.
With Lumiform, you report qualitative weaknesses in no time and quickly assign corrective actions to responsible colleagues. Easy communication with all team members and third parties allows you to improve internal processes and resolve incidents up to four times faster.
Digitise checklists and internal processes with Lumiform:
- The flexible form builder helps you turn your custom paper list into digital checklists in minutes.
- Using the super intuitive mobile app, you and your teammates can easily complete any exam on-site, saving time.
- All exam results are automatically bundled into one report and can be sent directly to the competent authority.