This guideline consists of general and specific requirements for the POA submission. The general requirements are referred for POA content whilst details of specific requirements are illustrated according to the test category.
9.1 GENERAL REQUIREMENTS
a) The POA shall be written in Bahasa Malaysia or English only.
b) The POA shall contain the following information:
- Name of product;
- Name and address of manufacturer;
- Name, signature and designation of authorized person;
- Effective date and Review date.
c) The POA shall comply with the following requirements :
- To provide updated testing methods, shelf-life specifications and certificate of analysis for the intended product to be registered.
- References used must be clearly stated.
- The latest version of British Pharmacopoeia (BP) and United State Pharmacopeia (USP) shall be used as the main references.
- All tests and its specification listed in BP and/or USP in General Monographs and Specific Monographs shall be the minimum requirement. However, a specific testing method for quantitative analysis shall be accepted.
- All test specifications set by the manufacturer shall be in line or more stringent than official pharmacopoeias (BP and USP).
d) Details of test methods shall include the following items:
- List of equipment and apparatus;
- List of chemical, reagents and media;
- Preparation of solutions such as sample, standard, mobile phase, medium etc.;
- Setting up of analytical instrumentation;
- System suitability tests (resolution, percentage of Relative Standard Deviation (%RSD), tailing factor and theoretical plate for High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) methods);
- Complete formula for calculation and interpretation of results;
- Specification or acceptance criteria.
e) Photocopies or methods directly copied from pharmacopoeias shall not be accepted. In cases where test methods are adopted from official pharmacopeia, details of specifics requirements should be submitted.
f) All relevant data collected during chemical and microbiological testing such as chromatograms HPLC/ GC, test reports and formulae used for calculating should also be submitted.
g) All documents should be arranged and labeled accordingly.
9.2 SPECIFIC REQUIREMENTS
The specific requirements for test methods are based on type of tests and dosage forms of product as stated in Table IX below:
|
Categories |
Type of Tests |
Specific Requirements |
|
Physical & Performance Tests |
Physical test (friability, uniformity of weight, pH, etc) |
Specific method for the intended analysis |
|
Disintegration test |
Specific method for related dosage forms |
|
|
Dissolution test |
a)Dissolution parameters should include:
b) Complete formula for calculation especially for extended and delayed release products. c) Method of analysis for example HPLC, UV, etc. |
|
|
Quality Test |
Identification test such as color test, Fourier Transform Infrared (FTIR), Thin Layer Chromatography (TLC) etc. |
Specific method for the intended analysis |
|
Impurities/ degradation/ purity test |
a) Analysis method should include:-
b) Complete formula for calculation c) Method of analysis for example HPLC, TLC, etc. |
|
|
Assay and uniformity of content |
Specific method for the intended analysis |
|
|
Biological Assay of Antibiotics |
a) Procedure for preparation of following solutions/ substances:-
b) Detailed test method (diffusion or turbidimetric method), which includes:
|
|
|
Safety tests |
|
|
|
Bacterial Endotoxins Test (BET) or Limulus Amebocyte Lysate (LAL) Test |
|
|
|
Sterility Test |
a) List of media and reagent
b) Preparation of media & Composition of Rinsing Buffer c) Preparation of test sample (including steps to eliminate antimicrobial activity due to antibiotic samples or samples which contain preservatives). d) Detailed test procedure for sterility test
|
|
|
Microbial Contamination Test |
Required for ALL non-sterile products
a) Preparation of test sample (including neutralizing of preservatives for samples that contain preservatives) b) Total Viable Aerobic Count
c) Test for Specified Microorganisms
For details, please refer circular; |
|
|
|
Quality Testing for Specific Ingredient |
For a product containing specific ingredient such as Aphanizomenonflosaquae, Red Yeast Rice (Monascus purpureus), ingredient(s) derived from seafood and placenta, please refer to Appendix 6 and Appendix 7 for the testing requirement(s). |
Note:
1. Finished product testing shall be conducted on every batch produced as per approved finished product specifications.
2. Manufacturer shall ensure that products manufactured locally or overseas are free from any contamination of Burkholderia cepacia. Please refer to these circulars for details:
Ref. (90)dlm.BPFK/PPP/01/03/ Jld. 2
Ujian Kontaminasi Burkholderia cepacia (19 December 2012).
3. Products are not allowed to send for gamma radiation treatment for the control of microbial contamination. Please refer to this circular for details:
Ref. (54)dlm.BPFK/02/5/1.3.
Aktiviti Pendedahan Produk Berdaftar kepada Sinar Gamma (18 April 2006)
