MHRA Questions and Answers For Specials Manufacturer's Con326474 PDF
MHRA Questions and Answers For Specials Manufacturer's Con326474 PDF
MHRA Questions and Answers For Specials Manufacturer's Con326474 PDF
1.
2.
Scope
3.
Q & As
4.
Glossary
5.
Reference documents
6.
Revision History
SCOPE
The guidance in this document is for the manufacture of products under
an MS licence. It is not intended to cover the importation of unlicensed
products although many of the expectations are common. The general
guidance within this document will also apply to radiopharmaceuticals.
This document does not contain any guidance relating to Advanced
Therapy Medicinal Products which came into operation in December 2008
in accordance with European regulation No 1394/2007.
Q & As
3.1 Quality Management
3.1.1
3.1.2
3.1.3
3.1.4
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3.1.5
3.1.6
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Batch Release (see also 3.2.1 for persons who can perform
release)
The order must be available in a written format (fax, mail,
email) at the time of product release. An order can be
received externally for an individual patient or internally to
manufacture a batch for stock replenishment.
3.1.7
3.1.8
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Pharmacovigilance
3.1.8.1 The requirements relating to suspected adverse
reactions are such that:
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3.2 Personnel
3.2.1
3.2.2
3.2.3
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3.3.2
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3.3.4
3.3.5
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3.4 Documentation
3.4.1
3.4.2
3.5 Production
3.5.1
3.5.2
3.5.3
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3.5.4
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3.5.5
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3.5.7
3.5.8
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3.5.14 What are the requirements regarding the key criteria for
labelling systems?
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Data is retrospective, and therefore less useful for batchspecific actions. Most products will have been released
before the information on colony count is available.
3.6.2
3.6.3
3.6.4
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3.6.7
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3.6.8
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Finished
Product
Reference
Samples
Would
typically
expect
reference
sample for
product
with shelf
life greater
than 90
days.
Comments
FP testing
may not be to
full spec
(release spec
must be
defined), but
should have
assurance
that product
would comply
with full
specification if
tested.
Would
typically
expect
reference
sample for
product
with shelf
life greater
than 90
days.
As per EU
Guide
For
products
with shelf
life of 90
days or
greater
FP testing
may not be to
full spec
(release spec
must be
defined), but
should have
assurance
that product
would comply
with full
on TPN.
Consideration
should be given
to batch
homogeneity
and validation of
manufacturing
process.
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specification if
tested.
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3.12.4
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unlicensed medicines?
The BP 2013 section V on unlicensed medicines states
under 'legal requirements' that: Imported unlicensed
medicines are outside the scope of the general monograph
on unlicensed medicines. However where an individual
monograph exists for an imported unlicensed medicine
then the product must comply. Note: requirements for
imported unlicensed medicines are listed in NHS guidance
section 5.5.
4
GLOSSARY
Closed systems
A closed system is defined as preparation by addition of sterile ingredients
to a pre-sterilised closed container closed to the atmosphere (a
hypodermic needle inserted through a rubber closure is commonly part of
a closed system. Use of a solution from an ampoule may be considered
part of a closed system provided the ampoule is opened within the
contained work station, only one withdrawal is made and the contents are
added immediately to the closed container.
Biological products
The biologicals manufacture box on the MS licence should be for sites
manufacturing the biological API / final bulk i.e. carrying out upstream
processing such as mammalian, bacterial and fungal cell culture, harvest,
then downstream processing and purification.
For the purposes of this Q&A, biological products excludes the
reconstitution compounding of commercial biological products such as
monoclonal antibodies, enzyme replacement therapies and peptide
hormones etc. These products may be prepared in shared facilities using
closed systems, where the risk of cross contamination is low, and there is
no risk of adventitious pathogen transfer.
CIVAS - centralised intravenous additive service
REFERENCE DOCUMENTS
5.1 The Pharmaceutical Journal Volume 281 dated 18th October 2008.
5.2 Aseptic Dispensing for NHS Patients - August 1995 Dr John Farwell
5.3
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REVISION HISTORY
Updated after internal and external consultation - August 2013.
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