Standard Operating Procedure of Listing of Qualified Personnel in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. The purpose of this document is to define procedure to determine a person as “Qualified Person” for performance of particular job / activity.
2. Scope:
2.1. This procedure is applicable to all personals who are performing a technical operation like dispensing, batch manufacturing, compression , filling etc at Plant.
3. Responsibilities:
3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. All Department Heads.
4. Procedure:
4.1. All HOD will maintain the list of Qualified Persons for particular operation.
4.2. All such lists will be supported by particular training and evaluation by concerned head.
4.3. All such lists will be reviewed by QA on Quarter basis for compliance.
4.4. QA will ensure that no operation / activity are being performed by Un-qualified persons.
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