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Recent Posts

Coronavirus, Supplier Qualification and Audit

  How is Covid-19 impacting your outsourcing responsibilities? During the next few months we will all be unable to travel to the extent that we originally planned.  We will have to explore alternative ways to fulfil regulatory requirement in order to do our part in...

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Technology Transfer

What does Technology Transfer mean to you? You have put a lot of work into developing a new drug substance and drug product.  Pre-clinical studies have been successful, and you have the necessary investment needed for your first clinical trial. You need to outsource...

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Sponsor Oversight of Vendors

Can you demonstrate appropriate oversight of your Vendors? Sponsors are required to have oversight of Vendors such as: Contract Manufacturing Organisations (CMOs) Clinical Research Organisations (CROs) What do the regulations say? Chapter 7 of EU GMP Guide requires...

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Opportunities at JW Quality Consulting

Due to a growing client base, JW Quality Consulting is looking to employ further personnel, on either a contract or employment basis.  We are looking for GMP specialists, who may already be experienced professionals, or alternatively may have some experience but be...

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Do you have a Straightforward Yet Robust GMP Process?

Let’s get back to basics This process map represents a back to basics, simple, robust process that, if implemented effectively, builds the RIGHT quality into any product type. A product that is safe, fit-for-purpose and consistent from batch to batch.  Driving the...

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Why do you Audit Your Suppliers?

We have been asked to conduct audits for a number of reasons and are conscious that you may be conducting audits for any of the reasons below. Do you conduct supplier audits because: the regulations say that we must? it’s best practise? there are project problems? you...

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Is writing your manufacturing instructions a challenge?

Writing easy to follow manufacturing instructions can more difficult than it initially seems. How do you ensure your documented processes become more structured, are fully defined and aligned with cGMP? How are your batch records formatted to ensure operators can...

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What’s in Your Product Specification File?

There seems to be as many interpretations of Product Specification File (PSF) requirements as there are the number of sites that we have visited. As contract QPs for Investigational Medicinal Products (IMPs) we have visited a number of manufacturing sites, either as a...

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