Frequently Asked Questions (FAQ)

Below you will find a selection of questions our clients often ask us about the services of PCS. We must note that this is not an all-encompassing list of questions. Please feel free to contact PCS at any time with any question you may have regarding GxP, Engineering, Training or other pharma/biotech/medical related questions.

Frequently Asked Questions (FAQ) By Clients

Questions are displayed in random order.

Russian GMP Certificate

Q: We are a pharmaceutical company and wonder if you could advise us on how to obtain a Russian GMP certificate.

A: We have compiled a document on the licensing of products for the Russian GMP. The document may be found following this link.

The most important thing to know is that unlike in the EU, the Russian procedure is decentralized. There is no single authority overseeing quality. There are separate entities for licensing of pharmaceutical activities, manufacturing and the registration of products.

PCS could not (within the time allocated to this question) find a definitive number (without having to invest more time), however a reputable source states that the fee is about 3 million Rubles (roughly 32,000 USD), it appears to be a one time fee. A source from 2010 states the following:

"The cost associated with registering a pharmaceutical product in Russia is actually comprised of two separate payments: one official payment to the state authorities (Roszdravnadzor) and another to the regulatory expert. Together, the payments can total approximately $49,000 (US). Of this sum, approximately $24,000–$36,000 can be accounted for by the official payments to FGU. This cost is associated with the examination of the dossier and the laboratory expertise; the latter cost will vary according to the number of dosages evaluated and the analytical methods. Not until the invoice for examination of the dossier is paid in full can the laboratory quality testing be undertaken, which is an integral part of the regulation process".

It is hard to say which source is right and whether or not the exchange rate between Rubles and USD was more favorable at the time. I would however take into account a margin for error.

Procuring a GDP License

Q: We are a hospital pharmacy seeking a GDP license for a new warehouse we are about to construct, can PCS assist us in the process?

A: PCS has provided a consultant to this client in order to guide them through the process. The consultant first mapped out the level of GDP-compliance before drawing up a formal plan of action that the hospital pharmacy should follow. In addition, PCS organized a one-day training on "the Responsible Person". This training was provided again for a second RP.

WHO Prequalification

Q: Dear PCS, we are a vaccine manufacturer and are looking for a partner who can help us with achieving WHO Prequalification.

A: PCS has organized a visit to the client's premises and conducted a "friendly" audit to assess the current status of the company. It was found that a number of deficiencies had to be resolved before the application were to be submitted. This involved upgrading the GMP awareness throughout the company, aligning the QMS with the core process and introducing a culture of quality. To achieve these goals, PCS has supplied a interim director QA.

Procuring a GDP License

Q: We are a hospital pharmacy seeking a GDP license for a new warehouse we are about to construct, can PCS assist us in the process?

A: PCS has provided a consultant to this client in order to guide them through the process. The consultant first mapped out the level of GDP-compliance before drawing up a formal plan of action that the hospital pharmacy should follow. In addition, PCS organized a one-day training on "the Responsible Person". This training was provided again for a second RP.

GMP Awareness

Q: We are a manufacturing organization facing an FDA inspection next year. We would like to increase the level of quality within our organization.

A: After conducting a one-day assessment at the company PCS has developed a comprehensive training program for this client whilst taking into account all layers of the organization. The training is focused on three core elements: improving communication within the company, management involvement and a better understanding of the QMS and GMP as a whole.

Implementing a Quality Management System

Q: We are a manufacturer of herbal medicine and looking to apply for a manufacturing license. We would need a consultant to set-up a QMS for us according to the GMP guidelines.

A: PCS has supplied three consultants to the project to implement GMP. The core objective of this assignment was to integrate the existing culture at the client into a GMP culture.

As the client was already ISO certified, PCS created a process-centered QMS approach whereby a gradual implementation of QMS elements made it easier for the client to adopt the new quality system.

Because of the process-centered approach, the client could focus on it's core task rather than the periphery of GMP. PCS has written the entire QMS documentation with input from the client and has performed (amongst others) Computerized Systems Validation (CSV) and Equipment validation. PCS also took care of the training needs of the client during the project.

Auditor Certification Program

Q: Can PCS organize a training for our corporate auditor certification program?

A: PCS has developed a six-day training program for these corporate auditors.

The training included every aspect of auditing including the non-technical aspects such as providing feedback

New Manufacturing Plant

Q: We are looking for a company that can implement a QMS based on our existing one at a new manufacturing facility we are building. In addition, could PCS supply a project manager and engineer for this project?

A: PCS has done a extensive review of the current QS at the client to be able to maintain the language, procedures and standards at the new facility. PCS supplied a Project Manager who could function as an Engineer at the same time.