CEI-MS-14 — procedure

§4Procedure

The procedure below is written in the second person, which is the only place in the Institute's document set where that register is used. A procedure is an instruction and is written as one.

1. Establish that the certificate identifies a specific batch by a code that appears on the container.
2. Confirm the presence of each critical field: product name and, where public, CAS number and molecular formula; batch code; identity by a method named, with the expected and determined values; chromatographic purity with the method conditions and the integration window; peptide content with the method by which it was obtained; water content; counter-ion identity and content; date of analysis; and the name of the laboratory that performed each determination.
3. Confirm the presence of each recommended field: appearance; solubility; residual solvents; aggregate content where the compound class requires it; endotoxin and sterility where parenteral use is contemplated; sequence restatement for compounds whose public sequence record is contested; and storage and retest conditions.
4. Assess internal consistency: the declared fractions must close to a mass balance within the tolerance of CEI-MS-03; the determined mass must be consistent with the stated formula; and the stated method must be capable of the reported determination.
5. Record the certificate as conformant where every critical field is present and internally consistent; as substantially conformant where every critical field is present with minor recommended gaps; and as not conformant otherwise.
6. Record the specific fields absent. A dossier entry stating that documentation is incomplete without saying which fields are missing is itself incomplete.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.