Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol to provide the written guidelines for execution of the installation qualification of Programmable Logic Controller (PLC) based HMI System for ________ Define the installation qualification […]

 Standard Operating Procedure (SOP) and Format for Instrument, Equipment usage logbook used for day to day activity and recording of usage details in pharmaceuticals. Equipment Usage Logbook 1.0   PURPOSE: This purpose of this SOP is to define the procedure for issuance, handling, making entries and review of   “Instrument/ Equipment usage logbook”. 2.0   SCOPE: This procedure […]

Standard Operating Procedure (SOP) and Protocol for Calibration of Laboratory Glassware (Class A)  like- Volumetric flask, Pipette calibration, Burette calibration used in Quality Control Laboratory for analysis purpose. Glassware Calibration Procedure 1.0   Purpose: The purpose of this SOP is to describe the procedure for calibration of laboratory glassware. 2.0   Scope: This SOP is applicable for […]

Standard Operating Procedure (SOP) for Preparation, Handling and Hold Time Study of Reference Solution. In analytical chemistry, a standard solution is a solution containing a precisely known concentration of an element or a substance. A known weight of solute is dissolved to make a specific volume. It is prepared using a standard substance, such as […]

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e., the Transferring Unit), thus ensuring that the Receiving Unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended Analytical Method […]

Standard Operating Procedure (SOP) for operation & calibration of digital microscope. A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with a lens that produces an enlarged secondary (virtual) image. Microscope – Operation & Calibration 1.0   Purpose: To lay down the procedure for operation and calibration […]

Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture and environmental control have not been consistently established, however, EU GMP requires inhalants to be manufactured in an ISO 8 environment and compendia, such as USP <1111> Microbiological Examination of Nonsterile Products. Procedure for Environmental […]

This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying those areas, such as compressed air, process gases, clean steam and water systems ENVIRONMENTAL MONITORING (EM) PROGRAM 1.0   OBJECTIVE : This Global Quality Standard (GQS) […]

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User Requirement Specification (URS) is a document that informs the software vendor / software on the users expectations from the software User Requirement Specification (URS) 1.0   PURPOSE: The purpose of this SOP is to establish procedure […]

Standard Operating Procedure (SOP) and Guideline for Validation of Analytical Method (AMV). The objective of validation of an analytical Method (AMV) is to demonstrate that it is suitable for its intended purpose. Procedure for Analytical Method Validation (AMV) 1.0   Objective : To lay down procedure for validation of Analytical Method (AMV) to be followed in […]

Standard Operating Procedure (SOP & Guideline) for swab test analysis. Swab test analysis is being done to avoid chances of cross contamination from one product to another. By this method we assure that the machine / equipment is free from active ingredients of previous product. Procedure for Swab Test Analysis 1.0   Objective : To lay […]

Standard Operating Procedure (SOP) for sampling of packaging materials (i.e. Aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/ Cap Child Resistant /Cap Non Child Resistant / PP Cap / Catch Box / Catron / Label etc. Procedure for Sampling of Packaging Materials 1.0   Objective […]

Standard Operating Procedure (SOP) for cleaning and operation of Alexander werk GmbH (Germany) make Roller compactor machine. Roller Compactor Machine 1.0   Purpose : The purpose of this SOP is to lay down the cleaning and operation procedure for Roller Compactor. 2.0   Scope : This SOP  is applicable for cleaning and operation of Roller compactor WP […]

Standard Operating Procedure (SOP) and Guideline for Preparation and Standardization of Volumetric Solution(s) used during analysis of Raw material and drug product at pharmaceutical quality control department. Preparation & Standardization of Volumetric Solution(s) 1.0   Objective : The purpose of this SOP is to describe a procedure for Preparation & Standardization of Volumetric solution. 2.0   Scope […]

Standard Operating Procedure (SOP) for procedure for Validation / Qualification of Steam Sterilizer used in microbiology laboratories. Validation of Steam Sterilizer 1.0   Purpose: To lay down the procedure for Validation of Steam Sterilizers. 2.0   Scope: This Standard Operating Procedure is applicable at microbiology section of Quality Control department. 3.0   References & Annexures: References: Health Technical […]