GMP Seminar (Annual and by clients’ orders)
Seminars conducted by CMPV aim to bring more knowledge about global GMP to clients, and are an opportunity and a platform where international experts from CMP Group come meet and share their practical experiences in relation to GMP compliance and implementation guidelines. Since Vietnam decided to go towards for compliance with global GMPs (PIC / S GMP) and other international GMPs required by the target markets (such as EU GMP, J-GMP, cGMP, etc.), this knowledge becomes much more useful for the pharmaceutical industry and related industries.
Annual seminars are held once per year in early Fall between August and September, and happened in Ho Chi Minh City so far. It will expand in the future to take place in Hanoi and / or Da Nang City.
Seminars by request is to be conducted at the location determined by the Client, very often right at the manufacturing site, that is convenient for the staff and operators of the factory to attend.
In any form of being organized, seminar program and contents will be proposed and edited by CMP Group experts to suit specific needs. Usually it will be sessions such as Basic knowledge of GMP, or intermediate GMP Course with specific topics related to the deep expertise that pharmaceutical operators may encounter in their daily operations.
Instructors/Speakers will be experts coming CMP Group, or they are guest speakers according to specific requirements.For more details, please press Contact us.
QMS / PQS Consultation
Support to build and improve Quality management systems (QMS/PQS) Our consultants can help clients build and reorganize quality management system (QMSs) and pharmaceutical quality systems (PQSs). They can also propose an ideal SOP documentation structure based on sound quality assurance policies. The service also covers documentation support, including master batch records (MBRs) for making reliable and efficient release, and SOPs and other records for assuring high quality manufacturing operations.
Output:
- GMP organization,
- QMS/PQS documentation management structures
- MBRs (for manufacturing/packaging), SOPs.
Gap Analysis and Inspection support services
In the reality, most of Vietnam’s pharma facilities have existed long time ago as a huge heritage left over from decades even before the war end. Compared to the period where those facilities were built, there are many huge changes now mostly in relation with regulatory updates, which require huge compliance done by manufacturers with much more new challenges. Properly in the pharmaceutical industry, GMPs even discriminant from different geographical areas require more severe compliance. Then came out the PIC/S, in spite that it unifies and uniforms local GMPs, its guidance shows all requirements are generally higher than what we comply with in Vietnam. Just because of that, pharma facilities that exist need to be renovated and improved to well match with different requirements of different GMPs of each market a pharma manufacturer aims to export to.
In order to have an overall understanding of the gap that should be between the current status of a facility and a condition required to comply with a specific GMP, a GAP Analysis should be adopted.
CMPV provides SMEs of GMP who come from Japan and other corners of the world to Vietnam for that purpose, assisted by CMPV’s local specialists. They will act as if they were pharma inspectors to assess and find out which issues or bad status the manufacturer may have and needed to be improved for a good compliance.
Gap Analysis report shall be the official statement submitted by CMPV to the Client when a Gap Analysis work finished. That report shall be a help to show how that facility is in terms of compliance and we include there our recommendations to the Client who will take into account to decide what they should do, whether to renovate or build a new plant, or others. Gap Analysis report serves to describe the real picture of a factory, realizing the opportunity and feasibility of renovating or building a new factory to reach a compliance.
At the same time, Gap Analysis report helps the investor roughly determine the total investment amount of a potential project even in both renovation and new construction of facilities.
Mock Inspection
CMPV is proud to be the company that provides this service very well to the Pharmaceutical Clients in Vietnam and is one of the earliest to bring this experience to Vietnam. We all understand that the results of inspections done by authorities (for pharmaceuticals, medical devices, or industries requiring specific inspections) are very important and affect a lot production and business operations of a Client. During an inspection, many issues from all aspects of the production site will be raised for analysis and asked by the inspectors to explain and/or clarify to prove its compliance of the facility, processing equipment and quality management systems at the premise of the client.
All efforts given from many aspects of the Client will be meaningless if they fail to pass this specific and critical inspection. In order for the Client to have the opportunity to practice and get familiar with the rigors of an inspection, as a rehearsal, Mock Inspection is just to serve this purpose. CMPV dispatches its senior experts who have decades of experience working before for multinational pharmaceutical corporations to Vietnam as mock inspectors. They will conduct “true-like” inspections in a same schedule at the Client’s premises. Throughout such mock inspections, the staff and operators of a Plant would have a valuable opportunity to familiarize themselves with the harshness, as well as make for themselves many valuable lessons, get them ready to enter a real inspection with more confidence in a much more ready position.
All the pre-inspection preparations, including this kind of mock inspection, will bring to the Client more promising success they can get at a much higher percentage possibility.