As per ICH Guideline,
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described.
When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The justification should refer to relevant development data, pharmacopoeial standards, test data for drug substances and drug products used in toxicology and clinical studies, and results from accelerated and long term stability studies, as appropriate. Additionally, a reasonable range of expected analytical and manufacturing variability should be considered.
Recommended Tests and Acceptance Criteria for Pharmaceutical Finished Product
Universal Tests/Criteria for Pharmaceutical Finished Product
The following tests and acceptance criteria are considered generally applicable to all new drug products:
a) Description: A qualitative description of the dosage form should be provided (e.g., size, shape, and color).
b) Identification: Identification testing should establish the identity of the new drug substance(s) in the new drug product and should be able to discriminate between compounds of closely related structure which are likely to be present.
c) Assay: A specific, stability-indicating assay to determine strength (content) should be included for all new drug products.
d) Impurities: Organic and inorganic impurities (degradation products) and residual solvents are included in this category.
Specific Tests/Criteria for Pharmaceutical Finished Product
In addition to the universal tests listed above, the following tests may be considered on a case by case basis for drug substances and/or drug products. Individual tests/criteria should be included in the specification when the tests have an impact on the quality of the drug substance and drug product for batch control. Tests other than those listed below may be needed in particular situations or as new information becomes available.
a) Dissolution: The dissolution specification for solid oral dosage forms normally includes a test to measure release of drug substance from the drug product. Single-point measurements are normally considered to be suitable for immediate-release dosage forms. For modified-release dosage forms, appropriate test conditions and sampling procedures should be established. For example, multiple time point sampling should be performed for extended-release dosage forms, and two-stage testing (using different media in succession or in parallel, as appropriate) may be appropriate for delayed-release dosage forms.
b) Disintegration: For rapidly dissolving (dissolution >80% in 15 minutes at pH 1.2, 4.0 and 6.8) products containing drugs which are highly soluble throughout the physiological range (dose/solubility volume < 250 mL from pH 1.2 to 6.8), disintegration may be substituted for dissolution.
c) Hardness/friability: It is normally appropriate to perform hardness and/or friability testing as an in-process control.
d) Uniformity of dosage units: This term includes both the mass of the dosage form and the content of the active substance in the dosage form; a pharmacopoeial procedure should be used.
e) Water content: A test for water content should be included when appropriate. The acceptance criteria may be justified with data on the effects of hydration or water absorption on the drug product.
f) Microbial limits: Microbial limit testing is seen as an attribute of Good Manufacturing Practice, as well as of quality assurance.
g) pH: Acceptance criteria for pH should be provided where applicable and the proposed range justified.
h) Endotoxins/Pyrogens: A test procedure and acceptance criterion for endotoxins, using a procedure such as the limulus amoebocyte lysate test, should be included in the specification.
i) Particulate matter: Parenteral products should have appropriate acceptance criteria for particulate matter.
j) Extractables: Control of extractables from container/closure systems is considered significantly more important for parenteral products than for oral liquids.
Pharmaceutical Finished Product Specification Template
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