(2) Good Manufacturing Practices Questions and Answers

Good Manufacturing Practices Questions and Answers (2)
Health Canada / Health Products and Food Branch Inspectorate
Equipment - C.02.005
Q. 1 Should equipment be labelled with calibration dates?
A.1 Major equipment should be identified with a distinctive number or code that is recorded in batch records. This identification requirement is intended to help document which pieces of equipment were used to make which batches of drug product.
Division 2, Good Manufacturing Practices (GMP), of the Food and Drug Regulations does not require that each piece of equipment bear status labelling as to its state of calibration or maintenance. However, equipment must be calibrated and/or maintained according to an established schedule, and records must be kept documenting such activities.
The regulations do not distinguish critical from non-critical equipment for calibration and maintenance purposes. However, the need for calibrating a given piece of equipment depends on its function. In general, equipment that measure materials warrant calibration. Equipment not requiring calibration/maintenance need not be tracked or included in the firm’s calibration/maintenance program, but the firm must be able to support its decision to exclude a particular piece of equipment from the calibration/maintenance program.
During an inspection a firm should be able to document when a specific piece of equipment was last calibrated/maintained, the results or action, and when its next calibration/maintenance is scheduled. The absence of such documentation is considered a GMP deviation. While the absence of a calibration/maintenance tag is not objectionable, the presence of a calibration/maintenance tag alone should not be assumed to satisfy regulatory demands, and the supporting documentation should be audited. The firm should also be able to support its decision to not include a particular piece of equipment in the calibration/maintenance program.
Personnel - C.02.006 (Updated)
Q.1 Is a company required to notify the Inspectorate of a change in key personnel, such as the person in charge of Quality Control (QC) or manufacturing department?
A.1 No. However, it is the company’s responsibility to make sure that the new person meets the requirements of Interpretation 1, 2, 3, or 4 under C.02.006 Personnel, depending on the activities performed.
(Good Manufacturing Practices Questions and Answers (2
(Good Manufacturing Practices Questions and Answers (2
10/15/2018 60 Number of visit:
Source: tehran darou.com

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