1.0 Objective: To lay down a procedure for the movement of material from one stage to another.2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 Store to … Read more
Various types of HPLC columns from the analytical point of view. know about what is an HPLC column? The column is the heart of the HPLC. The column stationary phase separates the sample components of interest using various physical and chemical parameters. It is usually made of stainless steel to withstand high pressure caused by … Read more
1.0 Objective: To lay down the procedure for operation of Filter Press.2.0 Scope: This procedure is applicable for the operation of the Filter Press in the liquid oral department.3.0 Responsibility:Production Officer, Production Executive. 4.0 Procedure:4.1 Assembling:4.1.1 The filter press consists of 9 sets of filter plates, mesh, and non-woven filter pads alternating with each other.4.1.2 … Read more
1.0 Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in the production area.2.0 Scope: This procedure is applicable to the monitoring of temperature, relative humidity, and differential pressure in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Recording of Temperature and relative humidity:4.1.1 … Read more
Aim: Methyl Orange Indicator Preparation | How to make w/v methyl orange Requirements: Glasswares: Burette, burette stand, conical flask, volumetric pipette, beaker, measuring flask, funnel, glass rod, wash bottle, storage container, etc. Chemicals: Methyl orange, Ethanol 20 ml, and Distilled water. Procedure for Methyl Orange Indicator preparation Related Post: Preparation and Standardization of 0.1 N HCl
1.0 Objective: To lay down a procedure for Inventory and storage of sieves, screens. 2.0 Scope: This procedure is applicable to Inventory management and storage of sieves, screens. 3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Inventory4.1.1 On intimation of receipt from stores, collect all the sieves/screens from the … Read more
To Preparation and Standardization of 0.1 N HCl utilizing sodium carbonate (also comprehended as washing soda, soda ash, and soda crystals) as the primary standard (Acid-base titration). Prerequisites for preparation and standardization of 0.1 N HCL: Glasswares: Burette, stand for burette, a conical flask, volumetric pipette to makeup volume, beaker, volumetric flask, funnel, glass rod, … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of new equipment/machinery / in-process product containers/accessories received. 2.0 SCOPE: This procedure is applicable to the cleaning of new equipment/machinery / In-process product containers/accessories in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S): Accessories: Sieves, screens. Spatulas, scoops SS jugs, … Read more
1.0 OBJECTIVE: 1.1 To define SOP on Change Control to be made in the authorized documents, validated methods, process, procedures, facilities, and equipment. 2.0 RESPONSIBILITY2.1 Assistant / Chemist / Executive – To initiate the Change Control Form.2.2 Respective Department Head – To evaluate and justify the required change.2.3 Other Departments Heads – To review and … Read more
1.0 OBJECTIVE: To lay down a procedure for handling products during a power failure in the production area.2.0 SCOPE: This procedure is applicable to the handling of products during a power failure in the production area.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality AssuranceManager – Production Department, Quality Assurance4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Action to be … Read more
Purpose: The goal of establishing Fundamentals of Validation SOPs is to help the parent business, affiliates, and contract manufacturers understand and maintain the validation program in order to meet GMP regulations. Responsibility: The quality assurance manager is responsible for developing and maintaining the validation program. Compliance with SOPs is the responsibility of departmental managers and contractors. … Read more
The objective of developing and executing this Risk Assessment Protocol is To access the Risk Associated with the Quality of the product with respect to hazards and critical point review. To evaluate the risk priority Number To identify the risk prevention steps. To identify the risk mitigation tools. 1.0 PROTOCOL APPROVAL: The Risk Assessment Protocol … Read more
PURPOSE: This Master Validation Plan will give general guidelines for which modifications, additions, and reconstruction will be made in such a way that validation of the facility will be possible. In addition to satisfying building, codes upgrades will have to satisfy Environmental Room requirements. SCOPE: Installation Qualifications and Operation Qualification will be conducted in the … Read more
India, as one of the most promising rising markets in the global pharmaceutical sector, offers tremendous prospects for all worldwide pharmaceutical companies to investigate and profit from. Mumbai is also a major contributor to providing all the major pharmaceutical products all over the world. if talk about pharma companies in Mumbai, lots of pharmaceutical manufacturing … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of paste preparation kettle.2.0 SCOPE: This SOP applies to the cleaning of the paste preparation kettle in the production area.3.0 RESPONSIBILITY:Operator, Officer, Executive –Production Department.Manager – Production Department. 4.0 PROCEDURE: This is a cleaning procedure for Change over of one batch to the next batch/ product … Read more
Warehouse personnel needs to check the few points which are most important to identify before the audit. the following Audit Check List Points for the Warehouse in pharmaceuticals are given below. Audit Check List Points for Warehousing / Distribution Area Audit Check List Points for Warehouse for RM sampling Room Each point of the checklist … Read more