Process Validation SOP and Protocol
Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which establishes scientific evidence and provides a high degree of assurance that a process is capable of consistently yield products meeting pre-determined specifications and quality attributes. SOP and Protocol for Process Validation of Drug Product 1.0 […]
Technology Transfer of Drug Product
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging, and analytical details. SOP on Technology Transfer of Drug Product 1.0 PURPOSE: […]
SOP for Rounding off the Analytical Test Results
Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances (RS) result and other laboratory generated quantitative value and their reporting system. SOP for Rounding Off Test Results 1.0 PURPOSE: The purpose of this SOP is to describe the standard for “Rounding off” […]
Microbial Culture Management
A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) 1.0 PURPOSE: To lay down the […]
SOP for Reduce Testing
Reduce Testing in Raw Material Standard Operating Procedure (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity of Quality Control for speedy release of RM. 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for reduce testing in analysis of raw materials.. 2.0 […]
SOP for Control Sample Management
Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material, Packaging Material, Drug Substance or Finished Drug Product which is stored to evaluate the potential risk during self life of the batch. Sample should be […]
Raman Analyzer – Handling Procedure (SOP)
The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has provided advantages over alternative ways in this. It doesn’t need sample pre-treatment or direct contact with the sample, and has the unique capability of having the ability to check a sample directly through a clear wadding like glass or plastic. With the additional benefit of portability, hand-held Raman spectrometers significantly increase potency/productivity by eliminating […]
Hold Time Study of Cleaned Equipment (CEHT)
Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness. To ensure the state of cleaning Hold time Study is required. This validation study to be executed for […]
Internal Audit (Self Inspection) Checklist
Internal Audit (Self Inspection) checklist for various departments of Pharmaceuticals like Quality Control, Quality Assurance, Production, HR and EHS etc. Below Internal Audit (Self Inspection) checklist being used for the assessment of respective departments . these are the minimum requirement for the compliance. It would be the agenda of Internal Audit (Self Inspection) checklist. Copy […]
SOP on Internal Audit and Self Inspection
In the SOP on Internal Audit and Self Inspection, describe the detailed procedure to carryout the the Self inspection and Internal Audit in various department of pharmaceuticals. Audit is a systemic and independent examination to determine the quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are […]
SOP For Operation of Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP)
The SOP for the operation of the Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) to define the comprehensive procedure for handling the waste of pharmaceuticals. Effluent Treatment Plant (ETP) – The mechanism or process used to treat the wastewater prior to release into the environment or its reuse. Sewage Treatment Plant (STP) -It […]
Annual Product Review (APQR / APR / PQR)
Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well as finding out the scope of quality improvement by controlling the critical process parameters (CPP). Visit to copy this SOP APR – Annual Product Review also known as APQR – Annual Product Quality Review and […]
Laminar Air flow (LAF) – Operation, Cleaning and Qualification
LAF : Laminar Air Flow – Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP. Laminar Air flow (LAF) – Operation, Cleaning and Qualification […]
Calibration of UV Spectrophotometer
Calibration of UV spectrophotometer (UV-VIS Spectrophotometer) for all parameters as per IP, BP and USP pharmacopoeia like, Internal Calibration, Match pairing of UV cell / cuvette, Control of wavelength, control of Absorbance, Limit of Stray light, Resolution and Resolution Power, Linearity Study and 2nd derivatives. UV Calibration / Calibration of UV Spectrophotometer : Parameters : […]
Cleaning and Sanitization in Pharmaceuticals
Cleaning and sanitization of Utility system and Equipment is crucial to maintain the Quality of the drug product and to avoid the cross contamination also Standard Operating Procedure for Cleaning and Sanitization PURPOSE: The purpose of this Standard Operation Procedure is Defines the requirements Ensure that facility and Equipment Cleaning and Sanitization are managed and […]
Water Analysis SOP as per IP/BP/USP
Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0 PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0 […]
Procedure for using of Molybdenum Kit
Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0 PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]
SOP for Line Clearance (LC) of Area and Equipments
Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0 PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]
SOP for Incident / Deviation Management
Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant. Handling and Control Procedure for Incident / Deviation 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]
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 […]
Water Analysis SOP as per IP/BP/USP
Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0 PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0 […]
Procedure for using of Molybdenum Kit
Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0 PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]
SOP for Line Clearance (LC) of Area and Equipments
Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0 PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]
SOP for Incident / Deviation Management
Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant. Handling and Control Procedure for Incident / Deviation 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]
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 […]
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