Professional Documents
Culture Documents
2. Scope
3. Q & As
4. Glossary
5. Reference documents
6. Revision History
This Q&A does not replace any of the requirements for unlicensed
medicines already contained in Guidance Note 14 (GN 14).
2 SCOPE
3 Q & As
3.1.6 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.
MHRA Questions and Answers for Specials Version1 4
manufacturer’s 20/9/13
3.1.8 Pharmacovigilance
3.2 Personnel
3.4 Documentation
3.5 Production
3.5.14 What are the requirements regarding the key criteria for
labelling systems?
3.6.3 How does the above requirement above apply when only a
single unit is produced?
3.6.6 What is the minimum frequency for media fills? What type of
manipulations should be simulated?
3.6.8 What are the requirements for growth promotion for media
used for environmental testing?
4 GLOSSARY
Closed systems
Biological products
5 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
MHRA Questions and Answers for Specials Version1 44
manufacturer’s 20/9/13
6 REVISION HISTORY