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.
Questions are displayed in random order.
Q: We are a pharmaceutical company and wonder if you could advise us on how to obtain a Russian GMP certificate.Show the Answer
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.
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?Show the Answer
Q: Dear PCS, we are a vaccine manufacturer and are looking for a partner who can help us with achieving WHO Prequalification.Show the Answer
Q: We are a manufacturing organization facing an FDA inspection next year. We would like to increase the level of quality within our organization.Show the Answer
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.Show the Answer
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.
Q: Can PCS organize a training for our corporate auditor certification program?Show the Answer
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
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?Show the Answer