Quality Agreement Technical (Contract Manufacturing)
Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject to cGMP. Technical Quality Agreement for Contract Manufacturing This “Quality Agreement” is made by and between Contract Giver a Company incorporated under the Companies Act, […]
Depyrogenating Tunnel – Qualification Protocol (PQ)
Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0 Objective: The purpose of this protocol is to provide an outline for the qualification of the Sterilizing and Depyrogenating Tunnel by verification of performance attributes such as: The PAO Penetration through installed HEPA Filters, […]
Reference Standard, Working Standard Handling
Procedure for Management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard. Working Standard / Reference Standard Management 1.0 Objective : To lay down procedure for management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard in Quality Control Department. 2.0 Scope : This SOP […]
Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared to the total number of batches produced, or the number of out-of-specification (OOS) results found by a QC lab, and which are then not confirmed […]
Dietary Supplements Recall Guideline
Guideline / SOP for Handling procedure to recall the Dietary Supplements from supply warehouse or market in case of a market complaint or defective product supplied in the market. Recall Procedure for Dietary Supplements 1.0 Purpose: This Standard Operating Procedure (SOP) describes in detail the recall procedure for Dietary Supplements. 2.0 Scope: This SOP is […]
Grounding Requirement for Equipment and Building
Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The requirements of this procedure are minimum requirements & it will be expanding if necessary. Requirements for Grounding Equipment and Building 1.0 Purpose: The objective of […]
Microbial Limit Test (MLT) of Non Sterile Product
Guideline (SOP) for quantitative enumeration of mesophilic bacteria & fungi that may grow under aerobic conditions and for detecting the presence of specified microorganisms in pharmaceutical raw materials and finished products (Microbial Limit Test – MLT). Microbial Limit Test (MLT) procedure 1.0 Purpose The purpose of this SOP is To lay down the procedure for […]
Microbiological Analysis of Material & Drug Product
Procedure & Guideline (SOP) for Microbiological Analysis of Raw Material (API & Excipient), In process sample and Finished drug product in pharmaceuticals. Microbiological Analysis of Drug Product / Material 1.0 Purpose: The purpose of this SOP is to define a procedure for Microbiological analysis of Raw material, in process samples and finished products. 2.0 Scope: […]
Reprocess Rework of API and Drug Product
Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0 Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]
21 CFR Part 11 : Electronic Records & Signatures
Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0 Purpose : The objective of this Guideline is to define the security controls for Computerized Systems that […]
Media Fill Test – Aseptic Process Simulation in Micro
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0 Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0 SCOPE This SOP shall be used as such […]
Local Area Network (LAN) Qualification Guideline
Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability of hardware as per requirement, guidance for re-qualification and to provide the procedure for numbering of network equipment. Qualification of Local Area Network (LAN) 1.0 […]
Out of Specification Result in Microbiology – Guideline
Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) Test Result in Microbiological Analysis. OOS results include all test results that fall outside of the specification or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. Handling of (Microbiology) Out-of-Specification (OOS) Results 1.0 Purpose The objective of […]
Validation Master Plan (VMP) Preparation Guideline
Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the pharmaceutical drug manufacturing plant. SOP for Validation Master Plan (VMP) 1.0 PURPOSE The purpose of this SOP is to lay down the procedure of preparation and control of the Validation Master Plan (VMP). 2.0 SCOPE […]
Quality Agreement Technical (Contract Manufacturing)
Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject to cGMP. Technical Quality Agreement for Contract Manufacturing This “Quality Agreement” is made by and between Contract Giver a Company incorporated under the Companies Act, […]
Depyrogenating Tunnel – Qualification Protocol (PQ)
Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0 Objective: The purpose of this protocol is to provide an outline for the qualification of the Sterilizing and Depyrogenating Tunnel by verification of performance attributes such as: The PAO Penetration through installed HEPA Filters, […]
Reference Standard, Working Standard Handling
Procedure for Management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard. Working Standard / Reference Standard Management 1.0 Objective : To lay down procedure for management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard in Quality Control Department. 2.0 Scope : This SOP […]
Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared to the total number of batches produced, or the number of out-of-specification (OOS) results found by a QC lab, and which are then not confirmed […]
Dietary Supplements Recall Guideline
Guideline / SOP for Handling procedure to recall the Dietary Supplements from supply warehouse or market in case of a market complaint or defective product supplied in the market. Recall Procedure for Dietary Supplements 1.0 Purpose: This Standard Operating Procedure (SOP) describes in detail the recall procedure for Dietary Supplements. 2.0 Scope: This SOP is […]
Grounding Requirement for Equipment and Building
Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The requirements of this procedure are minimum requirements & it will be expanding if necessary. Requirements for Grounding Equipment and Building 1.0 Purpose: The objective of […]
Microbial Limit Test (MLT) of Non Sterile Product
Guideline (SOP) for quantitative enumeration of mesophilic bacteria & fungi that may grow under aerobic conditions and for detecting the presence of specified microorganisms in pharmaceutical raw materials and finished products (Microbial Limit Test – MLT). Microbial Limit Test (MLT) procedure 1.0 Purpose The purpose of this SOP is To lay down the procedure for […]
Microbiological Analysis of Material & Drug Product
Procedure & Guideline (SOP) for Microbiological Analysis of Raw Material (API & Excipient), In process sample and Finished drug product in pharmaceuticals. Microbiological Analysis of Drug Product / Material 1.0 Purpose: The purpose of this SOP is to define a procedure for Microbiological analysis of Raw material, in process samples and finished products. 2.0 Scope: […]
Reprocess Rework of API and Drug Product
Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0 Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]
21 CFR Part 11 : Electronic Records & Signatures
Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0 Purpose : The objective of this Guideline is to define the security controls for Computerized Systems that […]
Media Fill Test – Aseptic Process Simulation in Micro
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0 Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0 SCOPE This SOP shall be used as such […]
Quality Agreement Technical (Contract Manufacturing)
Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject to cGMP. Technical Quality Agreement for Contract Manufacturing This “Quality Agreement” is made by and between Contract Giver a Company incorporated under the Companies Act, […]
Depyrogenating Tunnel – Qualification Protocol (PQ)
Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0 Objective: The purpose of this protocol is to provide an outline for the qualification of the Sterilizing and Depyrogenating Tunnel by verification of performance attributes such as: The PAO Penetration through installed HEPA Filters, […]
Reference Standard, Working Standard Handling
Procedure for Management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard. Working Standard / Reference Standard Management 1.0 Objective : To lay down procedure for management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard in Quality Control Department. 2.0 Scope : This SOP […]
Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared to the total number of batches produced, or the number of out-of-specification (OOS) results found by a QC lab, and which are then not confirmed […]
Dietary Supplements Recall Guideline
Guideline / SOP for Handling procedure to recall the Dietary Supplements from supply warehouse or market in case of a market complaint or defective product supplied in the market. Recall Procedure for Dietary Supplements 1.0 Purpose: This Standard Operating Procedure (SOP) describes in detail the recall procedure for Dietary Supplements. 2.0 Scope: This SOP is […]
Grounding Requirement for Equipment and Building
Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The requirements of this procedure are minimum requirements & it will be expanding if necessary. Requirements for Grounding Equipment and Building 1.0 Purpose: The objective of […]
Microbial Limit Test (MLT) of Non Sterile Product
Guideline (SOP) for quantitative enumeration of mesophilic bacteria & fungi that may grow under aerobic conditions and for detecting the presence of specified microorganisms in pharmaceutical raw materials and finished products (Microbial Limit Test – MLT). Microbial Limit Test (MLT) procedure 1.0 Purpose The purpose of this SOP is To lay down the procedure for […]
Microbiological Analysis of Material & Drug Product
Procedure & Guideline (SOP) for Microbiological Analysis of Raw Material (API & Excipient), In process sample and Finished drug product in pharmaceuticals. Microbiological Analysis of Drug Product / Material 1.0 Purpose: The purpose of this SOP is to define a procedure for Microbiological analysis of Raw material, in process samples and finished products. 2.0 Scope: […]
Reprocess Rework of API and Drug Product
Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0 Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]
21 CFR Part 11 : Electronic Records & Signatures
Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0 Purpose : The objective of this Guideline is to define the security controls for Computerized Systems that […]
Media Fill Test – Aseptic Process Simulation in Micro
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0 Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0 SCOPE This SOP shall be used as such […]
About the author
Subscribe Us
Popular Categories
Follow Pharma Beginners
Recent Post
-
Quality Agreement Technical (Contract Manufacturing)July 7, 2022/0 Comments
-
Depyrogenating Tunnel – Qualification Protocol (PQ)March 25, 2022/
-
Reference Standard, Working Standard HandlingFebruary 12, 2022/
-
Quality Metrics – New FDA GuidelineNovember 16, 2021/
-
Dietary Supplements Recall GuidelineNovember 11, 2021/
-
Grounding Requirement for Equipment and BuildingOctober 30, 2021/