Standard Operation Procedures
Standard Operation Procedures
Validation Master Plans
Quality Contracts

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Standard Operation Procedures
Creation and use of GMP equipment logbooks
HPLC Calibration - GMP SOP
Operation, calibration and maintenance of electronic analytical single pan balances
Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench
Hosting Regulatory Inspections - GMP SOP
Preventive maintenance (PM) procedure
Annual product review
Supplier certification program
Change control system
Calibration of dissolution test apparatus (USP apparatus 1 and 2)
Deviations (failure investigations, non-conformance)
Creating, reviewing, approving and issuing an SOP
Calibration program
GMP Document Management - GMP SOP
Corrective and preventive action (CAPA)
NDA Field Alert - GMP SOP
Supplier Audit Program - GMP SOP
Product Recall - GMP SOP
Self-inspection program
Batch reprocessing and reworking for API (active pharmaceutical ingredients)
Investigation of complaints
Handling Of OOS Results - GMP SOP
Returned Drug Products - GMP SOP
Classification Evaluation Approval Of Cleaning Agents - GMP SOP
Refrigerated Shipment - GMP SOP
Pest Control Program - GMP SOP
Handling Of Chemicals, Reagents And Solutions In Laboratories - GMP SOP