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
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
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
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
1.0 Purpose: To lay down a procedure for Locations, limits, and frequency of nonviable particle count.2.0 Aim: This SOP is applicable to nonviable particle count locations, limits, and their frequency in the Production facility.3.0 Responsibility:3.1 Sr. Officer / Officer & line coordinator shall execute this SOP.3.2 In-charge / Head shall supervise that the process is … Read more
1.0 Purpose: To lay down the procedure for packing vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccine vials in the Packing Section.3.0 Responsibility: 3.1 Trained operators and casual workers shall be responsible for packing activity.3.2 Officer/ Senior officer of Production shall be responsible for checking the activity.3.3 IPQA person shall be responsible … Read more
Goa is a state in western India with a coastline that goes all the way to the Arabian Sea. There is a presence of Small, Medium, and Large-Scale Pharmaceutical Companies. The majority of pharmaceutical companies are part of multinational corporations, as well as the Indian private and public sectors. Pharmaceutical companies in Goa deliver a … Read more
The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. The success rate of an audit relies on multiple factors, some of the Audit Check List for Quality Assurance are described below: 1.0 Quality Assurance Department 1.1 Does the company have a later quality … Read more
1.0 Purpose: To lay down the procedure for Receiving and Transfer the FGTN to Warehouse.2.0 Aim This Standard Operating Procedure is applicable to the packing Department in Pharmaceutical.3.0 Responsibility: 3.1 Trained operators/ line coordinators shall be responsible for receiving and transferring the material.3.2 Officer/Executives of production shall be responsible for checking the activity.3.3 IPQA in … Read more