Principles and Practice of Pharmaceutical Medicine

MA application, as accepted by the authorities.
Methods shall be updated in the light of scientific
advances, and modifications must be submitted for
approval.

Principles and guidelines for GMP

Quality management – implementation of qual-
ity assurance system.

Personnel – appropriately qualified, with speci-
fied duties, responsibilities and management
structures.

Premises and equipment – appropriate to inten-
ded operations.

Documentation.

Production – according to pre-established oper-
ating procedures with appropriate in-process
controls, regularly validated.

Quality control – independent department or
external laboratory responsible for all aspects
of quality control. Samples from each batch
must be retained for one year, unless not practic-
able.

Work contracted out – subject to contract,
and under the same conditions, without sub-
contracting.

Complaints and product recall – record keeping
and arrangements for notification of competent
authority.

Self-inspection – by manufacturer of his own
processes with appropriate record keeping.

Good manufacturing standards are enforced by
the Medicines Inspectorate of the Medicines
Control Agency. The United Kingdom has
been involved in the Pharmaceutical Inspection
Convention since its inception and, through the
Orange Guide, set standards which are now
reflected in the EC Directives.

Wholesale dealers’ licenses

This activity, established under the Medicines Act

1968, still remains wholly within the remit of

national regulatory authorities but in accordance

withDirective 92/25 EECon the wholesale distri-

bution of medical products for human use (Official

JournalL113/1–4 30 April 1992).

Routes of sale and supply

In the United Kingdom, the Medicines Act 1968

assumes that all medicinal products will be sold

through a pharmacy unless it is decided by the

Licensing Authority that supply of the product

should be limited to being dispensed only on a

registered medical practitioner’s prescription.

Such products appear on the Prescription Only

Medicines List and their packaging is marked

‘POM’. Certain products are also available through

outlets other than pharmacies and are designated as

General Sales List (GSL) products and listed as

such. Additional restrictions on supply are

imposed by the Misuse of Drugs Act 1971, and

the Misuse of Drugs Regulations substances that

havea potentialfor abuse are scheduled underthree

categories, classes A, B and C:

Class Aincludes alfentanil, cocaine, dextromor-

amide, diamorphine (heroin), dipipanone, lyser-

gide (LSD), methadone, morphine, opium,

pethidine, phencyclidine and class B substances

when prepared for injection.

Class Bincludes oral amphetamines, barbitu-

rates, codeine, ethylmorphine, glutethimide,

pentazocine, phenmetrazine and pholcodine.

Class Cincludes certain drugs related to the

amphetamines, such as benzphetamine and

chlorphentermine, buprenorphine, diethylpro-

pion, mazindol, meprobamate, pemoline, pipra-

drol and most benzodiazepines. Cannabis and

cannabis resin have been rescheduled as class

C, but were class B until 2003.

The Misuse of Drugs Regulations 1985 define the

classes of person who are authorized to supply and

33.3 THALIDOMIDE AND ITS AFTERMATH 431