SOP for Equipment Qualification
Standard Operating Procedure (SOP) for Qualification of Instrument, Equipment, Facility & Utility in the pharmaceutical manufacturing plant. Qualification: The action of proving and documenting that equipment or utility is properly installed, work correctly, and actually produce the expected results consistently. Procedure for Qualification of Equipment, Instrument, Facility & Utility 1.0 PURPOSE: The purpose […]
Data Integrity – Handling of DI Observations (DIO)
Standard Operating Procedure (SOP) for Handling of Data Integrity Observations (DIO) and Data Integrity Breach (DIB). Data Integrity is the extent to which all data are complete, consistent, truthful, traceable and accurate through the data life-cycle. Procedure For Handling of Data Integrity Observations 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) […]
SOP for Corrective Action and Preventive Action (CAPA)
Standard Operating Procedure for the handling of Corrective and Preventive Action (CAPA). Corrective and Preventive Action (CAPA) is a concept with current Good Manufacturing Practice (cGMP) that focuses on the systematic investigation of root causes of unexpected incidences to prevent their recurrence (corrective action) or to prevent their occurrence (preventive action) Handling of Corrective and Preventive Action […]
Procedure for Waste Disposal in Pharma
Standard Operating Procedure for Waste Disposal in Pharmaceutical plants. Waste can be classified as Hazardous Waste, E-Waste, Biological Waste, etc. SOP for Disposal of Waste Materials in Pharma 1.0 Purpose : The purpose of the SOP to provide the written guidelines for the disposal of various types of waste material generated in […]
SOP for BMR and BPR Review
Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as Filled Copy of Batch Manufacturing/Packing Records. Procedure for BMR & BPR Review 1.0 PURPOSE: The purpose of […]
SOP for Building Maintenance
Standard Operating Procedure for maintenance of the building in different seasons/weather for cracks, chocked and drainage systems in a pharmaceutical manufacturing plant. Building and facilities demand continue up keeping, repair works or up-gradation work for floor, wall, and ceiling. Whenever it happens painting, rack repair, floor repair, surrounding maintenance are done is called Building Maintenance. […]
SOP for material handling and movement (Procedure/Flow Chart)
Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department. SOP for Material Movement In Manufacturing Premises 1.0 PURPOSE: The purpose of this SOP is to lay down the procedure for material movement procedures […]
Out of Specification (OOS)- SOP and Formats
Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA and WHO guideline for Handling of Out of Specification (OOS) results. In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase […]
Calibration of Gas Chromatography (GC)
Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy, Calibration of Flame Ionization Detector (FID) by linearity Measurement, Calibration of Auto-injector by linearity measurement, Calibration for Column Oven temperature measurement, etc. SOP / Protocol for GC Calibration GC Calibration Procedure: At the time of calibration enter the details […]
SOP for Laboratory Instrument Qualification
Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory. Procedure for Laboratory Instrument Qualification 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for […]
Handling of Out of Trend (OOT) Analytical Test Results
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability out of trend (OOT) results describes as “A results that are within the specification but do not follow the trend, with respect to previous station […]
SOP for Sampling of Raw Material
Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Procedure for Raw […]
SOP for Dispensing of Raw Material
Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products. 1.0 PURPOSE: The purpose of this SOP is to define the procedure for dispensing of Raw Materials. 2.0 SCOPE: This procedure is applicable for dispensing of […]
SOP for Working/Reference Standard Qualification
Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for qualification, handling, storage and usage of reference standards (RS), calibration standards, impurity standards (IMS), […]
SOP for Electronic Data Management (Laboratory)
Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory. SOP for Electronic Data Management (Laboratory) PURPOSE The purpose of this Standard Operating Procedure (SOP) is; To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based […]
Vacuum Oven – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals. SOP for Vacuum Oven 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven. 2.0 SCOPE: This SOP is applicable for the […]
Dynamic Pass Box – Operation, Cleaning & Qualification
Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant. Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time. This process helps […]
Stability Chamber – Operation, Cleaning and Performance check
Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products. Handling of Stability Chamber/Oven 1.0 Purpose: The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven. 2.0 Scope: This procedure is applicable to the stability […]
Operation and Maintenance of Milli Q Water System
Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure. SOP for Milli Q Water System 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System. 2.0 SCOPE – SOP for Milli Q Water […]
Work Permit System in Pharma – SOP and Formats
Standard Operating Procedure (SOP) for Work Permit System in Pharmaceutical drug manufacturing plant. The work permit system is a formal written procedure used to control the hazards in non-routine work. The different work permit highlights the relevant hazards and precaution to be taken for the respective work before starting the activity. Procedure for Work Permit […]
Environment Health & Safety (EHS) Policy
Standard Operating Procedure for Environment, Health & Safety (EHS) Policy and procedure/practices at pharmaceutical drug manufacturing plants. Procedure / Policy: Environment, Health & Safety (EHS) 1.0 PURPOSE: The objective of the procedure is to define the company goal and driven procedures with respect to the top management. Establish the Environment, Health & Safety Management System […]
Industrial Hygiene – SOP & Guideline
The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants. Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant […]
Physical & Logical Control Policy of Computer System
Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy 1.0 Purpose: To define the process of the physical and logical security policy of the computer system. 2.0 Scope: This […]
Entry and Exit Procedure in QC Laboratory
Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant. Entry and Exit Procedure in QC Lab 1.0 PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area. 2.0 SCOPE: This procedure shall be applicable to the […]
Operation Procedure of 1010 KVA DG Set
Standard Operating Procedure (SOP) for the operation of 1010 KVA Diesel Generating – DG Set installed for power backup in the pharmaceutical drug manufacturing plant. Procedure for Operating of 1010 KVA DG Set 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the operation of the 1010 KVA DG set. 2.0 […]
Raw Material Reconciliation SOP
Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material. Procedure for Raw Material Reconciliation 1.0 PURPOSE: The purpose of this SOP is to define the procedure for raw material reconciliation. 2.0 SCOPE: This procedure is applicable to all raw materials for verification of […]
Purified Water – Sampling and Testing Procedure
Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0 PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0 REFERENCE: […]
Vacuum Oven – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals. SOP for Vacuum Oven 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven. 2.0 SCOPE: This SOP is applicable for the […]
Dynamic Pass Box – Operation, Cleaning & Qualification
Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant. Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time. This process helps […]
Stability Chamber – Operation, Cleaning and Performance check
Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products. Handling of Stability Chamber/Oven 1.0 Purpose: The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven. 2.0 Scope: This procedure is applicable to the stability […]
Operation and Maintenance of Milli Q Water System
Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure. SOP for Milli Q Water System 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System. 2.0 SCOPE – SOP for Milli Q Water […]
Work Permit System in Pharma – SOP and Formats
Standard Operating Procedure (SOP) for Work Permit System in Pharmaceutical drug manufacturing plant. The work permit system is a formal written procedure used to control the hazards in non-routine work. The different work permit highlights the relevant hazards and precaution to be taken for the respective work before starting the activity. Procedure for Work Permit […]
Environment Health & Safety (EHS) Policy
Standard Operating Procedure for Environment, Health & Safety (EHS) Policy and procedure/practices at pharmaceutical drug manufacturing plants. Procedure / Policy: Environment, Health & Safety (EHS) 1.0 PURPOSE: The objective of the procedure is to define the company goal and driven procedures with respect to the top management. Establish the Environment, Health & Safety Management System […]
Industrial Hygiene – SOP & Guideline
The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants. Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant […]
Physical & Logical Control Policy of Computer System
Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy 1.0 Purpose: To define the process of the physical and logical security policy of the computer system. 2.0 Scope: This […]
Entry and Exit Procedure in QC Laboratory
Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant. Entry and Exit Procedure in QC Lab 1.0 PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area. 2.0 SCOPE: This procedure shall be applicable to the […]
Operation Procedure of 1010 KVA DG Set
Standard Operating Procedure (SOP) for the operation of 1010 KVA Diesel Generating – DG Set installed for power backup in the pharmaceutical drug manufacturing plant. Procedure for Operating of 1010 KVA DG Set 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the operation of the 1010 KVA DG set. 2.0 […]
Raw Material Reconciliation SOP
Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material. Procedure for Raw Material Reconciliation 1.0 PURPOSE: The purpose of this SOP is to define the procedure for raw material reconciliation. 2.0 SCOPE: This procedure is applicable to all raw materials for verification of […]
Purified Water – Sampling and Testing Procedure
Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0 PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0 REFERENCE: […]
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