Posted in

The Backbone of Pharma: Understanding Quality Assurance SOPs

Quality Assurance SOPs

Understanding Quality Assurance SOPs : Quality Assurance SOPs play a crucial role in the pharmaceutical industry by outlining the procedures and guidelines that must be followed to ensure that products meet the required quality standards. These SOPs cover various aspects of the manufacturing process, from raw material testing to final product release, and are designed to minimize risks and errors that could compromise the safety and efficacy of pharmaceutical products.

List of all SOPs Related to Quality Assurance:

SOP for preparation of SOP
SOP for Data Integrity
SOP for in house code and numbers
SOP for Document control, approval, revision, and authorization
SOP for market complaints for market recalls
SOP for market returns and expiration goods
SOP for recovery from rejections
SOP for status labeling, color coding in premises
SOP for housekeeping audits
SOP for internal quality audits
SOP for checking, storage, and destruction of BMR/BPR and other production recodes
SOP for storage condition for finished goods
SOP for line clearance
SOP for total IPQA
SOP for process validation
SOP for cleaning method validation
SOP for testing method validation
SOP for purified water loop validation
SOP for batch control records
SOP for QA documentation
SOP for equipment/machine qualifications
SOP for approval of batch coding and overprinting on packing materials
SOP for stereo order, receipt, checking, and issue
SOP for the disposal of expired printed packing materials
SOP for deviation reports
SOP for operation cleaning, calibrations, and Maintainance of all machines and equipment
SOP for Investigation out of specifications (OOS)
SOP for OOT (Out of Trending)
SOP for Root Cause Analysis
SOP for change control
SOP for risk analysis, measurement, and controls.
SOP for Review of BMR and BPR
SOP for Good Documentation Practices
SOP for Specimen signature
SOP for Preparation, Approval and Execution of Validation Protocols and Reports
SOP for Validation Master Plans preparation, approval & review
SOP for FMEA (Failure mode & Effective Analysis)
SOP on Handling and Investigations of non-conformances
SOP for in-process checking
SOP for inspection and release of final goods
SOP on Technology Transfer
SOP For Failure investigation
SOP For Power failure
SOP For Acceptance Quality Level (AQL)
SOP For Operation of the data logger, monitoring of temperature and RH and evaluation of recorded data
SOP For Handling of product yield
SOP For Reconciliation of primary and secondary packing material

Leave a Reply

Your email address will not be published. Required fields are marked *