Quality
This category includes Quality Related SOP’s, i.e. Quality Assurance & Quality Control departments
HPLC Calibration Procedure as per IP
Standard Operating Procedure (SOP) and format/Protocol of HPLC system calibration as per newly released Indian Pharmacopoeia (IP) recommendations. This Procedure… Read More
Calibration of Instrument / Equipment Policy
Calibration Policy/SOP - Instrument calibration is one of the primary processes used to maintain instrument accuracy. Calibration is the process of… Read More
Media Fill Validation Procedure & Guideline
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of… Read More
Work Permit System (Safety)
Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time period.… Read More
Top Loading Balance – Operation and Calibration SOP
Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of… Read More
Data Integrity Incident Handling Procedure
Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of… Read More
Transport Validation – Guideline & Protocol
Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure… Read More
Documents and Data Control in Pharmaceuticals
Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose… Read More
Reprocessing Reworking & Redressing of Product
Reprocessing and reworking are considered non-routine events. Reprocessing: reprocessing is the introduction of an in-process material or drug product including… Read More
Tech Transfer Documents Handling Procedure
Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU)… Read More
GC Columns (Gas Chromatography) Management
Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. GC Column Management 1.0 … Read More
Reduce Testing Procedure for Raw Material (API)
Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender. Reduce Testing Procedure… Read More
Equipment Qualification Procedure and Protocol
Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality… Read More
Finished Product Release Procedure (SOP)
Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch… Read More
In Process Quality Assurance (IPQA) Check Points
Standard Operating Procedure (SOP) for In - Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product… Read More
Laboratory Investigation Checklist – OOS Result
Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of… Read More
Out of Specification (OOS) Handling Procedure
Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different… Read More
Vendor Assessment / Evaluation Checklist
Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability… Read More
Vendor Audit & Qualification Management Procedure
Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the… Read More
Stability Chamber / Incubator Management Procedure
Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to… Read More