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Checklist for Review of Analytical Raw Data (Chemical)
Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active Pharmaceutical Ingredient / Excipient), Inprocess samples and stability study sample analysis. Checklist for Review of Analytical Raw Data (Test wise) 1.0 Product Information (Review of Raw Data / Report) : Name of material […]
Stability Study SOP as per ICH Guideline
Stability study sop prepared according to ICH guidelines with required stability study sample incubation, sample pullouts and analysis of samples and summary. SOP for Stability Study of Drug Product 1.0 Purpose: The purpose of this SOP is to describe the procedure for sample collection, selection of batches, incubation, withdrawal, analysis, reporting, and evaluation, […]
SOP for Operation and Calibration of UV Cabinet
Standard Operating Procedure for Operation and calibration of UV cabinet for reviewing the TLC plate, Photolytic Degradation, UV cabinet Performance check. SOP for UV Cabinet (Operation & Calibration) 1.0 PURPOSE: The purpose of this Standard Operating Procedure ( SOP ) is to describe the procedure for suitability of the emission intensity of the […]
SOP for Audit Trail Review and Privilege Policy
In the Quality Control Laboratory of the pharmaceutical product manufacturing unit, Different instruments, and equipment being used to analyze the drug product. the documented tracking or list of activities known as the Audit trail. An audit trail can be either a paper or electronically based trail that provides a documented history of a transaction within […]
Isolation and Identification of Microorganisms
Standard Operating Procedure (SOP) for Isolation and Identification of Microorganisms (Microbes). Isolation and Identification of Microorganisms 1.0 PURPOSE: To lay down the Procedure for Isolation and Identification of Microorganisms. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department at the pharmaceutical manufacturing unit. 3.0 REFERENCE: SOP for […]
SOP for Quality Risk Management (Guideline ICH Q9)
Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. SOP for Quality Risk Management 1.0 PURPOSE: This Standard Operating Procedure (SOP) establishes uniform […]
Product Recall Procedure and Format
The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0 PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]
Change Control Management Procedure (SOP)
Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system. SOP for Change Control Management 1.0 PURPOSE: This standard operating procedure defines the requirements to ensure changes to systems (includes […]
Maintenance of Laboratory Instrument
Standard Operating Procedure (SOP) for maintenance of laboratory instrument i.e. preventive maintenance, breakdown maintenance, etc. SOP for Maintenance of Laboratory Instrument 1.0 Purpose: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of instrument maintenance and preventive maintenance. 2.0 Scope: This procedure is applicable to the Instruments at […]
SOP for GC Column Receipt, Performance Check and Storage
Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC Column: Receipt, Storage, Performance Check, Uses and Care 1.0 Purpose: The purpose of this SOP is to describe the procedure for the receipt, performance check, usage, and maintenance of GC Column. 2.0 […]
Receipt and Storage of Raw Material
Standard Operating procedure for receipt and storage of raw material. Starting material such as API and excipient required in the manufacturing of drug product. Receipt and Storage of Raw Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for receipt and storage of raw materials used in various products. […]
SOP for Disintegration Apparatus (DT)
Standard Operating Procedure (SOP) for disintegration apparatus (DT Apparatus) for operation and calibration as per IP containing various calibration parameters. Operation and Calibration of Disintegration Apparatus (DT) 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration, and cleaning of the disintegration apparatus. 2.0 SCOPE: This […]
Checklist for Review of Analytical Raw Data (Chemical)
Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active Pharmaceutical Ingredient / Excipient), Inprocess samples and stability study sample analysis. Checklist for Review of Analytical Raw Data (Test wise) 1.0 Product Information (Review of Raw Data / Report) : Name of material […]
Stability Study SOP as per ICH Guideline
Stability study sop prepared according to ICH guidelines with required stability study sample incubation, sample pullouts and analysis of samples and summary. SOP for Stability Study of Drug Product 1.0 Purpose: The purpose of this SOP is to describe the procedure for sample collection, selection of batches, incubation, withdrawal, analysis, reporting, and evaluation, […]
SOP for Operation and Calibration of UV Cabinet
Standard Operating Procedure for Operation and calibration of UV cabinet for reviewing the TLC plate, Photolytic Degradation, UV cabinet Performance check. SOP for UV Cabinet (Operation & Calibration) 1.0 PURPOSE: The purpose of this Standard Operating Procedure ( SOP ) is to describe the procedure for suitability of the emission intensity of the […]
SOP for Audit Trail Review and Privilege Policy
In the Quality Control Laboratory of the pharmaceutical product manufacturing unit, Different instruments, and equipment being used to analyze the drug product. the documented tracking or list of activities known as the Audit trail. An audit trail can be either a paper or electronically based trail that provides a documented history of a transaction within […]
Isolation and Identification of Microorganisms
Standard Operating Procedure (SOP) for Isolation and Identification of Microorganisms (Microbes). Isolation and Identification of Microorganisms 1.0 PURPOSE: To lay down the Procedure for Isolation and Identification of Microorganisms. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department at the pharmaceutical manufacturing unit. 3.0 REFERENCE: SOP for […]
SOP for Quality Risk Management (Guideline ICH Q9)
Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. SOP for Quality Risk Management 1.0 PURPOSE: This Standard Operating Procedure (SOP) establishes uniform […]
Product Recall Procedure and Format
The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0 PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]
Change Control Management Procedure (SOP)
Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system. SOP for Change Control Management 1.0 PURPOSE: This standard operating procedure defines the requirements to ensure changes to systems (includes […]
Maintenance of Laboratory Instrument
Standard Operating Procedure (SOP) for maintenance of laboratory instrument i.e. preventive maintenance, breakdown maintenance, etc. SOP for Maintenance of Laboratory Instrument 1.0 Purpose: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of instrument maintenance and preventive maintenance. 2.0 Scope: This procedure is applicable to the Instruments at […]
SOP for GC Column Receipt, Performance Check and Storage
Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC Column: Receipt, Storage, Performance Check, Uses and Care 1.0 Purpose: The purpose of this SOP is to describe the procedure for the receipt, performance check, usage, and maintenance of GC Column. 2.0 […]
Receipt and Storage of Raw Material
Standard Operating procedure for receipt and storage of raw material. Starting material such as API and excipient required in the manufacturing of drug product. Receipt and Storage of Raw Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for receipt and storage of raw materials used in various products. […]
SOP for Disintegration Apparatus (DT)
Standard Operating Procedure (SOP) for disintegration apparatus (DT Apparatus) for operation and calibration as per IP containing various calibration parameters. Operation and Calibration of Disintegration Apparatus (DT) 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration, and cleaning of the disintegration apparatus. 2.0 SCOPE: This […]
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