Does all equipment in pharmaceuticals need qualification? For example does carry strapping machine and bopp tapping machine need qualification?
Dear,
First you will prepare a equipment list and and decide critical and non-critical equipment after than only qualification to be perform on critical equipment’s
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Thanks for your quick response sir, if an equipment falls in to non critical category is it necessary to write down a SOP, are sops mandatory for all equipment? Please do answer in a regulatory prospects… thank you
We need to have SOP for all instruments / equipment’s. Criticality of instrument / equipment cannot be define when analysing number of products in laboratory. For eg. A sonicator used for degassing mobile phase may be non critical however when used for particle size solutions or used for quantitative analysis becomes critical.
As such we do not dedicate instruments / equipment however if it is consider for only one product SOP may not be required based on risk evaluation.
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hi for said equipment qualification required, pl find regulatory references
WHO GUIDELINE
Qualification
6.1 Qualification should be completed before process validation is performed. The process of qualification should be a logical, systematic process and should start from the design phase of the premises, equipment, utilities and equipment. TSR2006_Annexs1_5.indd 113 TSR2006_Annexs1_5.indd 113 4.5.2006 16:12:54 4.5.2006 16:12:54 114
6.2 Depending on the function and operation of the equipment, utility or system, only installation qualification (IQ) and operational qualification (OQ) may be required, as the correct operation of the equipment, utility or system could be considered to be a sufficient indicator of its performance (refer to Section 11 for IQ, OQ and performance qualification (PQ)). (The equipment, utility and system should then be maintained, monitored and calibrated according to a regular schedule.)
6.3 Major equipment and critical utilities and systems, however, require IQ, OQ and PQ.
EU ANNEX 15
USFDA guideline
Design of a Facility and Qualification of Utilities and Equipment Proper design of a manufacturing facility is required under part 211, subpart C, of the CGMP regulations on Buildings and Facilities. It is essential that activities performed to assure proper facility design and commissioning precede PPQ. Here, the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.
ICH Q7
5.12 Production equipment should only be used within its qualified operating range.
Thank you all for your response.I hope this interaction continues…