Billev Pharma East can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations. We have experienced and professional GMP auditors available to conduct supplier audits and we also offer audit-readiness assessments (mock audits) of your facility.
Pharmaceutical manufacturing is increasingly complex. Cost-pressures are leading pharmaceutical manufacturers to involve numerous new suppliers, as well as increasing employment in offshore production facilities. This can greatly increase quality risks in pharmaceutical manufacturing businesses because responsible producers tend to be less aware of the potential non-compliances of their suppliers/vendors/external service providers (suppliers). As part of current Good Manufacturing Practice (GMP) requirements, pharmaceutical manufacturers need to have implemented efficient GMP supplier management audit program.
In order to reduce the cost, pharmaceutical companies have increasingly become dependent on their suppliers for customer success. To gain an insight into supplier processes and eliminate the risks, it is crucial to conduct GMP supplier audit at the manufacturing premises of the supplier.
A GMP supplier management audit program is a formal process that aims to assess compliance with current GMP of all suppliers involved in the manufacturing of a pharmaceutical product, complementary medicine, or medical device. The aim of a supplier management audit program is to reduce quality risks and increase transparency and visibility of all manufacturing processes, including collecting, analysing, testing and reporting findings and implementing corrective action plans (e.g. CAPA).
Any activity covered by the GMP guidelines that is outsourced should be appropriately defined, agreed, and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality.
Legal basis defining the requirement for management of outsourced activities:
- Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Directive 2001/82/EC on the Community code relating to veterinary medicinal products
- Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
- Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
- EudraLex The Rules Governing Medicinal Products in the European Union Volume 4; EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Some basic principles and guidelines are also described in the ICH Q10 guideline on the Pharmaceutical Quality System.
The pharmaceutical quality system of the manufacturer of medicinal products should include the control and review of any outsourced activities. The manufacturer is ultimately responsible to ensure processes are in place to assure the control of outsourced activities. These processes should incorporate quality risk management principles (ICH Q9 guidelines on quality risk management).
Prior to outsourcing activities, the manufacturer is responsible for assessing the legality, suitability, and the competence of the supplier/vendor/external service provider (supplier) to carry out successfully the outsourced activities.
It is manufacturer’s sole responsibility to ensure that the supplier’s manufacturing processes, analytical tests and examinations are carried out reliably by the supplier and are in compliance with the applicable standards and regulations. After the audit, supplier must provide an appropriate corrective action plan with measures that will be implemented by the supplier within a defined timeframe to the manufacturer.
What should be checked during initial and/or routine audit?
- Quality Policy
Looking into the details of supplier’s quality systems should be utmost priority during a GMP supplier audit. Focus on identifying the non-conformances in quality process, production, packaging process, engineering changes, shipment, and invoicing at the supplier’s site.
- Training and Accountability
It is mandatory that the supplier has appropriate training program for new employees to meet the current GMP quality requirements. Accountability is the key to maintain integrity and consistency. If management comes forward to own the responsibilities for routine issues, employees will be encouraged to perform their parts in a dedicated manner.
- General Organisation
A well-organized and clean manufacturing facility reduces the chances of hazards and contamination. By auditing the supplier’s workplace, pharmaceutical manufacturer can have a good idea of how seriously the employees take their work. Organizational culture in the workplace apprises you of various facets of the supplier and may improve your confidence in them.
- Supply Access
Suppliers also rely on other suppliers for raw materials. When conducting a GMP supplier audit, evaluation of supplier’s access to various supplies is crucial.
In order to successfully perform the GMP supplier audit following steps should be followed:
- schedule a time for audit by contacting the supplier. Observe how they respond to proposal of performing supplier audit. Allow certain time for preparation; it would benefit both the parties. Inform the supplier on who the lead auditor will be and what resources would be required;
- prepare the outline of audit plan and review the supplier’s performance history. Generally, audit plan depends on reason behind conducting supplier audit. For example, if a discrepancy has been reported in the production area, more time should be spend there;
- conduct the audit as scheduled, at the same time keep the supplier’s schedule in mind. Their activities shouldn’t be hindered. Take a note of how the supplier’s team welcomes and greets you because this reflects the ethics and principles of the supplier;
- take a tour to the manufacturing premises, have a close look at the equipment’s and safety issues, pay attention to the GMP operations and waste disposal. Do not miss the supplier’s shipping policies, workforce strength and attitude of managerial as well as non-managerial staff;
- write down the complete audit report and support your points with evidence.. Discuss these with the supplier’s team because they may also have certain concerns;
when conducting the audit, keep your supplier as a partner.