Good manufacturing practices (GMP): Manufacture
of investigational medicinal products (IMPs)
Under the new directive, all
IMPs
need to be manufactured to
GMP1
to ensure that they are fit for consumption by patients and volunteers.
Richmond Pharmacology has a Good Manufacturing Practice License.
Exemption for hospitals and health centres
- 37.
- (1) The restriction imposed by regulation 36(1) shall not
apply to the assembly of an investigational medicinal
product where the conditions specified in paragraph (2)
are satisfied.
- (2) The conditions referred to in paragraph (1) are that
–
- (a) the assembly is carried out in –
- (i) in a hospital or health centre, and
- (ii) by a doctor, a pharmacist or a person
acting under the supervision of a pharmacist;
and
- (b) the investigational medicinal products are
assembled exclusively for use in –
- (i) that hospital or health centre, or
- (ii) any other hospital or health centre which
is a trial site for the clinical trial in which
the product is to be
used.2
A brief outline of the principles and guidelines governing Good
Manufacturing Practice for Medicinal Products:
Quality management
- To achieve quality manufacture of IMPs,
Quality Assurance (QA) systems need to
incorporate GMP guidelines and Quality
Control (QC).
- Full control and traceability of the changes made to product
specifications and manufacturing instructions during
development.
Personnel
- Appropriate training of all personnel involved with
IMPs
- The Qualified Person, with relevant knowledge, should be
responsible for ensuring that there are systems in place for
meeting the Annex requirements
Premises and equipment
- All risks of cross-contamination should be minimised, to be
reflected in the design of equipment and premises, inspection/test
methods and acceptance limits used after cleaning.
Documentation
-
Specifications and instructions
- Should be as comprehensive as possible and periodically assessed
during development with updates where necessary. Each new version
should be thorough and traceable to the previous document.
- Rationales for and consequences of changes should be recorded.
-
Order
- Should be precise, presented in writing, and formally authorised.
It should refer to the Product Specification File and the relevant
clinical trial protocol as appropriate.
-
Product specification file
- 'Should be continually updated as development of the product proceeds,
ensuring traceability to the previous versions'. It should include, or
refer to, a number of specific documents (see Annex 13 for a full
listing).
-
Manufacturing formulae and processing instructions
- Clear and adequate written instructions and records are to be
produced for every manufacturing operation or supply.
-
Packaging Instructions
- IMPs are normally packed in an individual way
for each subject included in the clinical trial. The number of
units to be packaged should be specified prior to the start of
the packaging operations, including quality control and retention
sample units. A sufficient reconciliation process must be
established.
-
Processing, testing and packaging batch records
- Concerns the detailing of batch records to accurately determine the
sequence of operations.
- Relates to the time that batch manufacturing records should be
retained.
Production
This section addresses:
- Packaging Materials
- Manufacturing operations
- Principles applicable to comparator product
- Blinding operations
- Randomised code
- Packaging
- Labelling
Quality control
- Includes the parameters for performing quality control and
information on the retention of samples of
IMPs.
Release of batches
- A listing of the Qualified Person's duties of the with regard
to IMPs in different circumstances.
Shipping
- An outline of the shipping regulations for IMPs,
including decoding arrangements and inventory information.
Complaints
- Complaints procedure and the parties involved.
Recalls and returns
- Procedures for retrieving and returning IMPs
should be agreed by the sponsor. This section also covers the
storage and inventory records of returned IMPs.
Destruction
- The sponsor is responsible for the destruction of unused and/or
returned IMPs. Therefore written authorisation
must be obtained from the Sponsor before IMPs
can be destroyed.
- A dated certificate or receipt of destruction must be provided to
the sponsor when IMPs are destroyed. This section
outlines the information to be included in the documentation.
- Next:
Non-NHS
Research Ethics Committees (RECs)
- Previous: Obtaining authorisation
to conduct a clinical trial
- Contents