SOP on Monitoring Temperature, Relative Humidity, and Differential Pressure

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

Methyl Orange indicator Preparation | How to make w/v Methyl Orange

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

SOP on Inventory and Storage of Sieves, Screens

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

Preparation and Standardization of 0.1 N HCl

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

SOP on cleaning of new equipment/machinery

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

SOP on Change Control / FDA Change Control

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

SOP on Handling Products During a Power Failure

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

Fundamentals of Validation SOP

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

Risk Assessment Protocol in Pharmaceuticals

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

Facility Upgrade Master Validation Plan

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

List of Pharma Companies in Mumbai, Maharashtra

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

SOP on Cleaning of Paste Preparation Kettle

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

Audit Check List Points for Warehouse

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

List Of Pharma Company In Hyderabad

Hyderabad Pharma City is the “world’s largest pharmaceuticals industrial park” being built by the Telangana government near Hyderabad, India. The Park, which spans 19,000 acres, is billed as the largest of its kind industrial cluster for pharmaceutical businesses’ manufacturing and development needs. There are Big giants, mid-level, and small-cap companies if talk about the top … Read more

SOP on Cleaning and Operation of Printing and Rewinding Machine for Labels.

1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of printing and rewinding machine for labels.2.0 Aim: This Standard Operating Procedure is applicable for cleaning and operation of printing and rewinding machines for labels.3.0 Responsibility:3.1 Trained line -Coordinators for cleaning and operation of the machine.3.2 Officers/ Sr. officers shall respectively supervise … Read more

Audit Check List for Engineering Department

The audit is an important element in deciding the development and market presence of any organization, mainly in the pharmaceutical Feild. The success of an audit leans on numerous factors, some of the Audit Check List for the Engineering Department are described below: 1.0 Audit Check List for Engineering Related to Support System 1.1 HVAC … Read more