QMS and Orange Guide 2017
Dear Medicines and Healthcare products Regulatory Agency,
I am writing to you under the Freedom of Information Act 2000 to request the following information.
1. What Quality Management System (QMS) for vaccine manufacturers and distributors, including appointed third-party suppliers and contractors, is applicable to products produced under a Conditional Marketing Authorisation?
2. If this is different to Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2017 (Orange Guide), please provide copies and related documentation, including risk assessments carried out on the alternative QMS.
3. If Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2017 (Orange Guide) are applicable, please provide confirmation that the MHRA Inspection, Enforcement and Standards Division is documenting and sharing reports relating to compliance with Good Manufacturing and Distribution Practice (GMDP) across the entire supply chain, along with providing copies of inspection reports from May 2020 – May 2021. (or any 3 sequential months within this time frame).
4. In particular where the company sponsoring the Conditional Marketing Authorisation outsources manufacture and/or distribution, the provisions for outsourcing contained in The Orange Guide are complied with in full. Please provide confirmation that written agreements (Contracts) are in place between all actors in the supply chain as required, along with relevant documentation.
Please provide the information in the form of a return email. If any of the questions are not able to be answered please try to answer the others as fully as possible and if possible, state the reason for the information not being available.
If it is not possible to provide the information requested due to the information exceeding the cost of compliance limits identified in Section 12, please provide advice and assistance, under the Section 16 obligations of the Act, as to how I can refine my request.
If you can identify any ways that my request could be refined, I would be grateful for any further advice and assistance.
If you have any queries please don’t hesitate to contact me via email or phone and I will be very happy to clarify what I am asking for and discuss the request, my details are outlined below.
Thank you for your time and I look forward to your response.
Yours faithfully,
Mark Oakford
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Our Ref: FOI 21/578
Dear Mark Oakford,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 27^th May 2021.
I confirm that your request is now being handled under the Freedom of
Information Act and you should receive a reply within 20 working days from
our date of receipt.
If you need to contact us again about this request, please quote the
reference number above.
Please be aware that we publish FOIs replies and these are redacted and
are located on our website at the following link below.
[1]https://www.gov.uk/government/collection...
Kind Regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
11^th June 2021
Dear Requestor,
REF: FOI 21/578
Thank you for your information request, dated 27^th May 2021, where you
asked for information relating to vaccine manufacturers and distributors;
and the QMS and GMP controls in place.
We are pleased to provide you with some of the information requested, see
below.
1. As detailed in the ‘Orange Guide’; the Quality Management System (QMS)
Is a standard expectation, regardless of the dosage form being
manufactured and the legal status of the medicinal product being
supplied (e.g. Clinical Trial Authorisation, full or conditional
Marketing Authorisation).
2. The Quality Management System (QMS) Is described within the Rules and
Guidance for Pharmaceutical Manufacturers and Distributors; of which
the current published version is the 2017 Orange Guide within the UK.
3. MHRA Licencing assessors together with the Inspection, Enforcement and
Standards Division as needed, review each supply chain for medicinal
products as per the submitted marketing authorisation application. The
standard Inspection Process is described here;
[1]https://www.gov.uk/guidance/good-manufac...
This details the expectations placed upon manufacturers and
distributors of medicinal products, the inspection process and
outcomes. The confirmation of compliance is published as GMP or GDP
certification; found here [2]https://cms.mhra.gov.uk/mhra/gmp
4. I can confirm that we do not hold the information that you have
requested.
a. Where the company sponsoring the Conditional Marketing
Authorisation outsources manufacture and/or distribution; this
contract management is facilitated by the sponsoring company. The
management of outsourced activities is assessed during GMP
inspections to ensure compliance with Good Manufacturing
Practice. Such reviews and assessments during inspection are
representative and copies of associated written agreements are
not held by the MHRA.
If you have any further query, please do not hesitate to contact us at
[3]IE&[email address]
If you are unhappy with our decision, you may ask for it to be reviewed.
That review will be undertaken by a senior member of the Agency who has
not previously been involved in your request. If you wish to pursue that
option please email: [4][MHRA request email]
Due to the ongoing Covid-19 situation, we are not able to accept delivery
of any documents or correspondence by post or courier to any of our
offices.
After that, if you remain dissatisfied, you may write to the Information
Commissioner at;
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.
Yours sincerely
IE&S FOI Team
MHRA
Inspection, Enforcement and Standards
cc FOI_Policy
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