Data Integrity Principle
Data Integrity Principle Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required
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Oryol
Drug product salvaging as per USFDA CFR 211.208
Drug product salvaging as per USFDA CFR 211.208 Drug products that have been subjected to improper storage conditions including extremes
Read MoreExpiration dating as per USFDA CFR 211.137
Expiration dating as per USFDA CFR 211.137 (a) To assure that a drug product meets applicable standards of identity, strength,
Read MoreStability testing as per USFDA CFR 211.166
Stability testing as per USFDA CFR 211.166 (a) There shall be a written testing program designed to assess the stability
Read MoreGeneral requirements For Laboratory Controls as per USFDA CFR 211.160
General requirements For Laboratory Controls as per USFDA CFR 211.160 (a) Any production, control, or distribution record that is required
Read MoreLaboratory records as per USFDA CFR 211.194
Laboratory records as per USFDA CFR 211.194 (a) Laboratory records shall include complete data derived from all tests necessary to
Read MoreComplaint files as per USFDA CFR 211.198
Complaint files as per USFDA CFR 211.198 (a) Written procedures describing the handling of all written and oral complaints regarding
Read MoreDistribution records as per USFDA CFR 211.196
Distribution records as per USFDA CFR 211.196 Distribution records shall contain – The name and strength of the product Description
Read MoreProduction record review (USFDA CFR 211.192)
Production record review (USFDA CFR 211.192) All drug product production and control records, including those for packaging and labeling, shall
Read MoreReturned drug products (USFDA CFR 211.204 )
Returned drug products (USFDA CFR 211.204 ) Returned drug products shall be identified as such and held. If the conditions
Read MoreEntry And Exit Of Personnel In The Plant
Entry And Exit Of Personnel In The Plant OBJECTIVE: To lay down a standard procedure for the Entry and Exit
Read MoreInduction of New Employees
Induction of New Employees OBJECTIVE: To lay down a standard procedure for the acquaint newcomers with all the systems and
Read MoreCleaning Of Insecticutor
Cleaning Of Insecticutor OBJECTIVE: To lay down a standard procedure for cleaning of Insecticutor. SCOPE: This SOP is applicable to
Read MoreDress Washing, Issue and Control
Dress Washing, Issue, and Control OBJECTIVE: To lay down a standard procedure for dress washing, issue, and control. SCOPE: This
Read MoreMedical Examinations of Employees
Medical Examinations of Employees OBJECTIVE: To lay down a standard procedure for Medical Examination of all employees and to ensure
Read MorePersonnel Hygiene & Cleanliness
Personnel Hygiene & Cleanliness OBJECTIVE: To lay down a standard procedure for educating the employees about personnel hygiene, cleanliness, and
Read MorePest And Rodent Control
Pest And Rodent Control OBJECTIVE: To lay down a standard procedure for pest & rodent control on the premises. SCOPE:
Read MorePreparation of Disinfectant for Uniforms
Preparation of Disinfectant for Uniforms OBJECTIVE: To lay down a standard procedure for preparation and usage of the disinfectant on
Read MoreRecruitment Of Employee
Recruitment Of Employee OBJECTIVE: To lay down a standard procedure to recruit and appoint the right people in the right
Read MoreSafety and Safety Measures
Safety and Safety Measures OBJECTIVE: To lay down a standard procedure to aware personnel of safety and safety measures to
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