A risk assessment protocol in pharmaceuticals is a document used for risk assessment of product quality from hazards and critical points. Its objective is to assess the risk associated with product quality. It evaluates the risk priority number (RPN). It also identifies risk prevention steps and risk mitigation tools. 1.0 PROTOCOL APPROVAL: The following persons … Read more
A facility upgrade master validation plan sets guidelines for modifications, additions and reconstruction so the facility can be validated and meets Environmental Room requirements. Installation Qualification and Operation Qualification are carried out on upgraded elements. Positive pressure is ≥ 0.05 in. water and temperature is 15 – 30°C, each monitored for a minimum of 72 … 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
This SOP on cleaning of paste preparation kettle explains how to clean the paste preparation vessel after batch changeover or contact-part maintenance. Operators soak it in purified water, scrub with a nylon scrubber, rinse, dry, and wipe with 70% w/w IPA. They then update status labels and record times in the usage log. 1.0 Objective … 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
The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. the success of an audit relies on multiple factors, some of the audit Audit Checklist for Quality Control are described below: 1.0 Audit Checklist Quality Control Department 1.1 Does the QC lab have SOPs … Read more
1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of carton coding machine.2.0 Aim: This SOP is applicable to the carton coding machines installed in the Production. 3.0 Responsibility:3.1 Line operator shall be responsible for cleaning and operation of carton coding machine3.2 Officer / Sr. Officer shall be responsible for supervising … Read more
1.0 Purpose: To describe the procedure for decontamination of used material that comes in contact with API.2.0 Aim: This Standard Operating Procedure is applicable for the decontamination of used material in the production department. 3.0 Responsibility: 3.1 Trained line coordinators shall carry out the decontamination process of used materials.3.2 Officers/Sr. Officers shall be responsible to … Read more