(6) Good Manufacturing Practices Questions and Answers

Good Manufacturing Practices Questions and Answers
Health Canada / Health Products and Food Branch Inspectorate
Quality Control Department - C.02.013, C.02.014 & C.02.015
Q.1  If a product fails its particulate matter specifications, can it be released for sale?
A.1  No. The particulate matter requirement is treated in the same way as any other specification: failure would constitute non-compliance with the labelled standard. 
Q.2  Are the United States Pharmacopoeia (USP) general notices enforceable?
A.2  Yes. The USP General Notices provide in summary form the basic guidelines for interpreting and applying the standards, tests, assays, and other specifications of the USP so that these general statements do not need to be repeated in the various monographs and chapters throughout the book. Where exceptions to the General Notices exist, the wording in an individual monograph or general test chapter takes precedence.
This concept is further emphasized in the introduction to the General Information chapters which states, "The official requirements for Pharmacopeial articles are set forth in the General Notices, the individual monographs, and the General Tests and Assays chapters of this Pharmacopeia." The General Tests and
Assays chapters are those numbered lower than 1000.
Q.3  If a lot meets United States Pharmacopoeia (USP) specifications but fails the firm’s internal specifications, can it be released?
A.3  If a lot does not meet its declared release specifications, then the lot should not be released. Where more stringent internal specifications act as an alert limit and not as the basis for release, then the lot may be released after investigation and justification provided it meets its release specifications.
Q.4  Is it acceptable for firms to export expired drugs for charity?
A.4  No. While it is recognized the dire need for drugs in distressed parts of the world, once the expiration date has passed there is no assurance that the drugs have the safety, identity, strength, quality and purity characteristics they purport or represent to possess. As such, expired drugs are considered adulterated and their introduction or delivery for introduction into commerce is prohibited.
Q.5  Explain the United States Pharmacopoeia (USP) measurement uncertainty (MU) requirement for balances.
A.5  USP General Chapter <41> Weights and Balance states a weighing device providing accurate weighing for assay and test is to have MU of less than 0.1% of the reading and gives an example of 50 mg ± 50 :g as acceptable. To qualify MU of a balance, an appropriate National Institute of Standards & Technology (NIST) traceable weight within the weighing range of the balance is weighed 10 times or more. The resulting weights are calculated so that three times the calculated standard deviation divided by the amount weighed should be less than 0.001.
For different balance class designations and detailed information on weights and balance, the USP General
Chapter <41> is to be consulted.
Q.6  Can an older version of an official method be used or must the most updated version always be used?
A.6  In resolving issues of conformance to an "official standard", the most up to date version of the analytical method is the method that must be used to determine compliance.
Q.7  What is the Inspectorate’s position on the use of secondary reference standards (RS) and what are 
the conditions for the use of secondary reference standards?
A.7  While the Inspectorate recommends the use of the official standards for the analysis of compendia articles, the use of a secondary RS is acceptable if each lot’s suitability is determined prior to use by comparison against the current official reference standard and each lot is requalified periodically in accordance with a written protocol. The protocol should clearly address the receipt, storage, handling and use of primary reference standards, the purification of secondary standards, and their qualification against official reference standards.
Q.8  Is it acceptable to use a third party lab’s available pharmacopeial reference standard to qualify an establishment’s secondary standard?
A.8  This practice is acceptable providing the contract testing lab has an Establishment Licence (EL) and has been audited by the client to demonstrate its capability to qualify the secondary standard (i.e., the official standard and the proper equipment is available on the tester's premises, the method used has been validated, etc.). Transfer of the standard between the sites should be under controlled conditions.
Q.9  What is the Inspectorate’s position on the use of loose work sheets as opposed to bound notebooks for the purpose of recording laboratory data?
A.9  The recommended method of recording laboratory data is a bound book but the use of loose work sheets would be acceptable as long as it is controlled by a system or a procedure to ensure that all raw data are true and accurate, properly recorded and captured, adequately maintained and easily retrievable. The system should also provide accountability and traceability of work sheets.
Q.10  It is generally accepted in the industry to perform process validation on three consecutive lots. How does the Inspectorate view validation when reworking is required (i.e., three consecutive incidents will never happen)?
A.10  Reworking of a batch should be a very rare occurrence. As such, validation of reworking is not considered mandatory as it is not generally feasible. The reworking should be carried out in accordance with a defined procedure approved by Quality Control (QC) and with the conditions described in Interpretation 6
of Section C.02.014 Quality Control Department. This procedure should include supplementary measures and testing during the reworking operations to ensure that the quality of the final product is not compromised.
It is mandatory that rework proposals and reworked product also be fully investigated with respect to impact on release characteristics and potential impact on bio-availability. Changes in formulation due to reworks including the incorporation of additional lubricant or dissolution aid or additional critical processes may require comparative bio-availability studies. Furthermore concomitant stability studies must be undertaken on reworked batches to ensure that critical characteristics are not compromised with time due to the rework.
Q.11  Is it mandatory for the approval of a procedure to sign each page or is it acceptable to only sign the first page?
A.11  It is not mandatory for the approvers to sign each page of the procedure. It would also be acceptable to only sign the last page.
(6) Good Manufacturing Practices Questions and Answers
(6) Good Manufacturing Practices Questions and Answers
11/26/2018 41 Number of visit:
Source: tehran darou.com

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