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Finished Pharmaceutical Product Specifications. Rutendo Kuwana. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Control of FPP. Four subsections Specifications Analytical procedures Validation of analytical procedures

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Finished Pharmaceutical Product Specifications

Rutendo Kuwana

Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009

control of fpp
Control of FPP

Four subsections


Analytical procedures

Validation of analytical procedures

Batch analysis (against full set of specifications)

Full info on three or more batches e.g.

Batch number and size

Date/place of manufacture and QC testing

Purpose of batches

Batch number of API


specifications for the fpp
Specifications for the FPP

Specifications are one part of a total control strategy for the FPP designed to ensure product quality and consistency

Others include sound development studies and adherence to GMP; e.g., suitable facilities, a validated manufacturing process, in-process testing, stability testing, API testing, etc.


biobatch vs specifications
Biobatch vs Specifications

For the PQP, specifications should be designed to ensure consistency with the biobatch. This then becomes the starting and central point for dossier assessment

steps in setting specifications
Steps in setting specifications
  • Identify critical product and process atributes
  • Evaluate regulatory requirements
  • Evaluate stability trends
critical product attributes
Critical Product Attributes
  • Safety
  • Efficacy
  • Quality
  • Physical
  • Chemical
  • Microbiological
  • Biological
  • Functionality
product attributes example oral suspension
Product Attributes – Example, Oral Suspension
  • Presentation to the Patient
  • Child resistant closure
  • Tamper evident packaging
  • Accurate dosing of correct medication
  • Description (appearance, colour, odour)
  • Identification (API, Preservatives)
  • Dose delivery device (Physical characteristics of liquid – viscocity, particle size)
  • Uniformity of content, resuspendability, dissolution
specifications for the fpp8
Specifications for the FPP

Should be as stated in the Pharmacopoeia; or


End of shelf life

the concept applies only to products and establishes more restrictive criteria for the release of the product

Compendial requirements – General chapters e.g. Dissolution, residual solvents AND specific monographs


fpp specifications 2
FPP specifications (2)

Important reading for setting specifications:

ICH guideline Q6A (also good for generics):Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.

ICH Q3B (R2): impurities in new drug products

ICH Q3C (R3): Impurities – Guidelines for Residual Solvents

ICH Q8 (2): Pharmaceutical development

ICH Q10: Pharmaceutical quality system


specifications based on compendial monographs
Specifications based on Compendial monographs
  • Additional product related specifications, e.g.
    • Those standard for the type of dosage form (e.g. friability, tablet hardness, mass uniformity, viscosity)
    • ID of colorants (skip testing?)
    • microbial limits (skip testing?)
    • ID and assay of preservatives
    • Limits may be tighter than in monograph
fpp specifications typical parameters 2
FPP specificationsTypical parameters (2)


Identification of the following in FPP


Colorants (skip testing possible)


Physical tests appropriate to dosage form e.g.

LOD, friability, hardness (tabs)

Uniformity of dosage units (mass / content)

Pharmaceutical tests, e.g.


Each API in FDC products


fpp specifications typical parameters 3
FPP specificationsTypical parameters (3)

Purity tests

Degradation products (related substances)

Special attention to API-API degradation products

Residual solvents (solvents used in process)

Microbial count / sterility / bacterial endotoxins

Content of APIs in FPP (assay)

Limits 95.0% – 105.0%, unless justified

Content of preservatives

Limits 90.0% – 110.0%, generally acceptable


analytical procedures
Analytical procedures
  • Should be presented with sufficient detail to enable the procedure to be repeated by another laboratory
  • If a test is based on a Pharmacopieal monograph, a copy of the monograph + any methods referenced in the monograph must be submitted
  • Details of any specifications and test methods additional to those in the pharmacopoiea must be submitted
general requirements for justification of specifications
General Requirements for justification of specifications
  • It is normally not necessary to test the FPP for synthesis impurities that are controlled in the API and are not degradation products
  • 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
  • Test results from stability and scale-up / validation batches, with emphasis on the primary stability batches, should be considered in setting and justifying specifications.
use of reference standards
Use of reference standards
  • If a primary reference standard is available, then it should be used
  • When not available, then a reference standard should be developed and qualified (See ICH Q6A) – information on tests to establish identity, purity and assay value should be provided
  • Secondary working standards – content should be assayed relative to the primary reference standard using the same assay method