Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non- clinical and clinical data. This process is governed and permitted by Drug Regulatory […]

Standard Operating Procedure for On-site Emergency Plan : The main purpose of the on Site Emergency Plan is for effective mobilization of resources in order to: save lives, rescue victim, minimize injury, timely treatment to the injured personnel, Identify the dead / casualty and minimize the extent of the damage to the resources, inform relatives […]

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. This guideline provides the procedure for Handling and Reporting of serious breaches of Good clinical practices (GCP). GOOD CLINICAL PRACTICES (GCP) – HANDLING AND REPORTING OF SERIOUS BREACHES 1.0   OBJECTIVE […]

Standard Operating Procedure (SOP) and Protocol for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department. Microbiologist Qualification 1.0   PURPOSE : The purpose of this Standard Operating Procedure (SOP) is to lay down the Procedure for Microbiologist Qualification (validation) to establish and assure that Microbiologist is […]

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, […]

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, […]

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 […]

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 […]

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 […]

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 […]

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 […]

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: […]

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) […]

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 […]

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 […]