Contract QP Services
This is the mainstay of our service offering which we can provide for up to 3 companies at a time, within the Central Belt area of Scotland. We’ve been doing this for over 15 years, with many long term engagements lasting 5 -10 years. This service is much more than just batch release - to do it properly we need to get into the bones of your organisation and Pharmaceutical Quality System, and we’ll work with you to ensure that your compliance program is effective and meets all key GMP requirements and regulatory expectations. We’ve helped small companies, where initial batch forecasts might not be sufficient to justify a full- time QP role, as well as helping more mature companies manage batch release demands with our flexible and results driven approach. We’ve accompanied many of Scotlands best small GMP start-ups on that journey, and like nothing better than to see an engagement come to a natural end because the company has grown sufficiently to recruit / train their own permanent QPs, and we’ve helped to mentor trainee QP candidates along that journey.
Training
Probably our favourite service offering… we love getting people together in a room to share experiences (including the bitter ones - often how learning sticks best!), to get to know colleagues better, and to develop staff by giving them the tools and education that they need to react with confidence and thrive in their roles. We love putting together punchy, interactive training (with quizzes/assessments that genuinely confirm understanding) as it benefits the trainer every bit as much as the trainees. If you want to truly understand something, prepare to explain it to 15 curious colleagues! We’ve delivered training on just about every GMP topic - including refresher and induction sessions, as well as tailored sessions based on whatever our clients require (recent examples include use of AI in GMP, Sterility Assurance, EM and OOS investigations, how autoclaves work…) and according to delegate feedback, we have even made pharmaceutical law interesting!Audits
Audits have been another mainstay of our service offering since 2010. We’re approaching our 200th on-site audit performed… that’s a lot of reports! Every one of those sites audited do at least one thing well - this is of great value in seeing best practices first hand. There are many different approaches to achieve GMP compliance, as long as they are scientifically sound, protect patient safety, and meet core regulatory requirements. We’ve probably all experienced audits by GMP auditors who’ve worked for one company for 30 years and think it’s the only way things can be done, but life’s not that simple (or boring). At BioChem QP Consulting, we ensure we take a structured, pragmatic, and risk-based approach, and we spend at least 1/3 of the audit time on the shop floor - where aspirational procedures collide with operational reality. We ALWAYS respect our client’s relationships with auditee companies, and having sat many times on the other side of the table, treat all people encountered with respect and courtesy. This shouldn’t need saying - but it does. The outcome of an audit should not just be a report and CAPA plan for the QP to read, but genuine understanding of key opertations, and new relationships & contacts who can help out if things go wrong…
Contract QP
Named on your MIA or MIA(IMP)
manufacturing licence
Training
Sharing our 25 years experience
and knowledge to help develop
your GMP / QA staff
Audits
Building on our experience of
>150 pharma site audits since
2010 - specialising in APIs,
steriles, biologicals, ATMPs
Our Key Services
We treat each enquiry on its merits, and are happy to engage with queries of any type from quick questions to full service contracts… but our main service offerings fall
into the folloing 3 main areas - Contract QP Services, Training, and Audits
Address
BioChem QP Consulting Clyde Offices 48 West Regent Street Glasgow, G2 1BP Scotland, UKHow to get in touch
So, whatever your requirements are, even if they don’t fit neatly into one of the three boxes above, give us a call, message us on LinkedIn, or drop an email to our enquiries inbox at the address below. We’re always happy to have an initial chat, even if it’s just to recommend someone from our extensive network of valued and experienced industry contacts, who might be better placed to help with your particular requirements…
Contract QP Services
This is the mainstay of our service offering which we can provide for up to 3 companies at a time, within the Central Belt area of Scotland. We’ve been doing this for over 15 years, with many long term engagements lasting 5 -10 years. This service is much more than just batch release - to do it properly we need to get into the bones of your organisation and Pharmaceutical Quality System, and we’ll work with you to ensure that your compliance program is effective and meets all key GMP requirements and regulatory expectations. We’ve helped small companies, where initial batch forecasts might not be sufficient to justify a full-time QP role, as well as helping more mature companies manage batch release demands with our flexible and results driven approach. We’ve accompanied many of Scotlands best small GMP start-ups on that journey, and like nothing better than to see an engagement come to a natural end because the company has grown sufficiently to recruit / train their own permanent QPs, and we’ve helped to mentor trainee QP candidates along that journey.
Training
Probably our favourite service offering… we love getting people together in a room to share experiences (including the bitter ones - often how learning sticks best!), to get to know colleagues better, and to develop staff by giving them the tools and education that they need to react with confidence and thrive in their roles. We love putting together punchy, interactive training (with quizzes/assessments that genuinely confirm understanding) as it benefits the trainer every bit as much as the trainees. If you want to truly understand something, prepare to explain it to 15 curious colleagues! We’ve delivered training on just about every GMP topic - including refresher and induction sessions, as well as tailored sessions based on whatever our clients require (recent examples include use of AI in GMP, Sterility Assurance, EM and OOS investigations, how autoclaves work…) and according to delegate feedback, we have even made pharmaceutical law interesting!Audits
Audits have been another mainstay of our service offering since 2010. We’re approaching our 200th on-site audit performed… that’s a lot of reports! Every one of those sites audited do at least one thing well - this is of great value in seeing best practices first hand. There are many different approaches to achieve GMP compliance, as long as they are scientifically sound, protect patient safety, and meet core regulatory requirements. We’ve probably all experienced audits by GMP auditors who’ve worked for one company for 30 years and think it’s the only way things can be done, but life’s not that simple (or boring). At BioChem QP Consulting, we ensure we take a structured, pragmatic, and risk-based approach, and we spend at least 1/3 of the audit time on the shop floor - where aspirational procedures collide with operational reality. We ALWAYS respect our client’s relationships with auditee companies, and having sat many times on the other side of the table, treat all people encountered with respect and courtesy. This shouldn’t need saying - but it does. The outcome of an audit should not just be a report and CAPA plan for the QP to read, but genuine understanding of key opertations, and new relationships & contacts who can help out if things go wrong…
Contract QP
Named on your MIA or MIA(IMP)
manufacturing licence
Training
Sharing our 25 years experience
and knowledge to help develop
your GMP / QA staff
Audits
Building on our experience of
>150 pharma site audits since
2010 - specialising in APIs,
steriles, biologicals, ATMPs
Our Key Services
We treat each enquiry on its merits, and are happy to engage
with queries of any type from quick questions to full service
contracts… but our main service offerings fall into the folloing
3 main areas - Contract QP Services, Training, and Audits
