Case Studies

1) On Demand Auditing for Pharmaceutical Companies

The PCA Group performs a large number of GMP Audits for clients. During these projects, the PCA Auditors act as part of the companies audit team. By using the client’s templates and SOPs, the PCA Auditors act like internal Auditors of the company. With this service we offer our clients the option of a flexible additional capacity. The PCA Partners have experience in different areas. For that reason we are able to let one Partner perform an Audit of a QC contract lab and another auditor perform an Audit of a fermentation process. Other colleagues are specialised in auditing computer software suppliers, medical devices or blood donor services etc. Many more areas can be covered by our GMP specialists. This is why more and more companies use so called Third Party GMP Audits from the PCA Team

2) Access to the EU market – GMP Compliance of Manufacturing Sites Located Outside of the EU

The European pharmaceutical market has a comprehensive regulatory structure. Manufacturing sites located outside of the EU need to fulfil exactly the same regulatory requirements as those located in the EU. In order to obtain the manufacturing (import) authorization, it is required (among others) that the company:

- have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 20;
- have at his disposal the services of at least one qualified person within the meaning of Article 48.

To meet these and further requirements companies ask the PCA team for support. The PCA Partners contact the competent authority and are involved in all necessary activities.

3) Preparing manufacturing sites for EU and/or FDA Compliance

Normally we start a project by performing a GAP Analysis. This GAP Analysis will inform the clients about the current GMP situation of the facility concerned. The length of the audit depends on the complexity of the manufacturing site and the number of products. The PCA Partner will perform a comprehensive analysis of the documents available at the manufacturing site before the audit will be performed, e.g. Site Master File, certain SOPs, Validation Plan, Batch Record etc). As a result of the document analysis and the GAP inspection on site a comprehensive report will be developed which contains a to-do list and a GAP analysis Normally the PCA partners continue the support after the audit by managing the project list. This means that the PCA partner will manage the oversight over the project plan and monitors the milestones of the project. On request the PCA partner prepare certain GMP documentation for the clients, e.g. SOPs, Validation Master Plan etc. PCA Partners also support clients by contacting the relevant competent authority in charge of the marketing authorisation or of the manufacturing authorisation.

4) GMP Mock Inspections – GMP Due Diligence Audits

Mock Inspections are a frequently requested service offered by the PCA Partners. Pharmaceutical or API companies who are facing a regulatory inspection (e.g by FDA, EU authorities) want to know the level of GMP compliance. Companies who ask for this service are located in the EU but also outside the EU. In some cases the clients had problems with previous regulatory inspections. They worked hard to meet the requirements and they want to make sure that the next regulatory inspection will be a success. The PCA partners perform a GMP inspection just like a regulatory authority would perform it. This will help the clients to evaluate the current status and to fix GMP areas which have been found not in compliance with the GMP requirements. When we perform GMP Due Diligence Audits we help our clients to evaluate a manufacturing site. This might be useful before a production site will be purchased by a company. Here the auditor is not only looking for GMP deviations but also for potential risks (e.g. necessary investments in the next years to come).

You can contact us if you have a similar project or a different quality related problem.

PCA Publications

Sterile Production According To the New EU GMP Annex 1: A Focus On Capping

Regulations governing sterile manufacture of pharmaceuticals have been significantly revised since their introduction. The recent amendment to Annex 1 has seen the most controversial changes relating to the capping of vials. Pharmaceutical Inspection Cooperation Scheme has provided an interpretation of the guidelines and has published a report that offers advice on how to comply with the new recommendations. Capping is the particular focus of this article published in Pharmaceutical Technology Europe.

Detecting GMP failures

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens? Read more in this article published in Pharmaceutical Technology Europe.