Pharmaceutical Guidance Complete Pharma Solution
- Sampling and testing of Sterile surgical Gloves
- INPROCESS CONTROL OF CAPSULE MANUFACTURING
- PROCEDURE FOR CALIBRATION OF REFRIGERATOR
- USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS
- List of Documents required for Quality Control Departments (GMP & GLP Compliances)
- List of Documents required for Quality Assurance Departments (GMP Compliances)
- In-process control of oral drug product during manufacturing & Packing
- SAMPLING OF PACKING MATERIALS
- PROCEDURE FOR OPERATION OF UNIT DOSAGE SAMPLER
- Batch Release Statement for Pharmaceutical Product
- Procedure for Microbiological Monitoring of Purified water
- Inprocess Control of Packing Lines
- Sampling of Intermediates and Finished Products
- Inprocess Control During Tablets Manufacturing
- SOP on Line Clearance
- SOP on the Transfer of Technology for Analytical Method
- SOP on Transfer of Technology for Manufacturing process
- SOP on Fogging of Microbiology Testing Areas
- SOP on cleaning and operating procedure of bursting strength tester
- Handling of Microbiological Data Deviation in Microbiology Laboratory
- Technology transfer
- Correction of Documentation Errors
- New Product Design and Development Process
- Approval of vendors (Packing Materials)
- Vendor Development and Approval (API and excipients)
- Cleaning validation
- PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER
- Unit Dose Sampling Procedure for Blend Uniformity
- Management Review
- Temperature Mapping
- Code to Code Transfer of Materials and Additional Testing of Materials / Products
- CALIBRATION MASTER PLAN
- SOP on In-process sampling of semi-finished product
- SOP on execution of exhibit batches
- SOP on withdrawal, storage, observation & destruction of control / retention sample
- SOP on preparation, control, issuance and revision of Batch Manufacturing and Batch Packing Records
- SOP on line clearance
- SOP on Monitoring of Temperature, Relative Humidity and Pressure Differential
- SOP on Technology Transfer for Analytical Method
- SOP on Transfer of Technology for Manufacturing process
- SOP on Execution of Exhibit Batches
- Preparation, hahdling, storage and discard of mobile phases
- SOP on Training
- SOP on Drug Product Recalls
- Issuance and Evaluation of Product Exception Investigation Reports (“EIRs”).
- SOP on Process Validation Programmed in Pharmaceutical Company
- Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products
- Procedure for calibration of weighing balances
- Calibration procedure for halogen moisture analyser
- Handling of Returned Pharmaceutical Products