(2003; 148 pages)
Starting and packaging materials
17.14 Before releasing a starting or packaging material for use, the quality control manager should ensure that the materials have been tested for conformity with specifications for identity, strength, purity and other quality parameters.
17.15 An identity test should be conducted on a sample from each container of starting material (see also section 14.14).
17.16 Each batch (lot) of printed packaging materials must be examined following receipt.
17.17 In lieu of testing by the manufacturer, a certificate of analysis may be accepted from the supplier, provided that the manufacturer establishes the reliability of the supplier’s analysis through appropriate periodic validation of the supplier’s test results (see sections 8.8 and 8.9) and through on-site audits of the supplier’s capabilities. (This does not affect section 17.15). Certificates must be originals (not photocopies) or otherwise have their authenticity assured. Certificates must contain at least the following information (6):
(a) identification (name and address) of the issuing supplier;
(b) signature of the competent official, and statement of his or her qualifications;
(c) the name of the material tested;
(d) the batch number of the material tested;
(e) the specifications and methods used;
(f) the test results obtained;
(g) the date of testing.
17.18 In-process control records should be maintained and form a part of the batch records (see section 15.25).
17.19 For each batch of drug product, there should be an appropriate laboratory determination of satisfactory conformity to its finished product specification prior to release.
17.20 Products failing to meet the established specifications or any other relevant quality criteria should be rejected.