The FDA 483 is a form that FDA issues to companies after inspection. It contains the list of violations of FDA regulations in the facility. This FDA 483 form gives the company a chance to fix the listed issues. An FDA 483 doesn’t always mean serious problems. Sometimes they are minor issues like improper ...

A New Drug Application is submitted to the FDA when any company wants to bring a new drug in the market. The purpose of the submission of the NDA is to get approval for the marketing of the new drug in the US market. There are many benefits of submitting a new drug application for FDA approval, some ...

Following are some frequently asked questions and their answers that will help you to understand the topic better. Q1: Why is cleaning validation important in pharmaceutical manufacturing? Ans: Cleaning validation has great importance in pharmaceutical manufacturing because it ensures product quality, ...

Rank Company Market capitalization (December 2023) 1 Sun Pharma ₹295,466 crore (US$37 billion) 2 Cipla ₹100,787 crore (US$13 billion) 3 Dr. Reddy’s Laboratories ₹98,218 crore (US$12 billion) 4 Divi’s Laboratories ₹96,242 crore (US$12 billion) 5 Mankind Pharma ₹76,792 ...

1.0 PURPOSE: To define a procedure for control of data integrity issues at manufacturing location. 2.0 SCOPE : 2.1 This procedure applies to all the employees working in all the departments and applicable to all GMP documents throughout its lifecycle, of …………….. 3.0 REFERENCE(S) & ATTACHMENTS 3.1 ...

1.0 OBJECTIVE: To lay down the procedure for Daily Work Allotment. 2.0 SCOPE: This SOP is applicable for Daily Work Allotment in Quality Control Department. 3.0 RESPONSIBILITY: Officer, Executive– Quality Control Department. Head – Quality Control Department. 4.0 PROCEDURE: 4.1 Section Head of each ...

1.0 OBJECTIVE: To lay down the procedure for Qualification of Water System. 2.0 SCOPE: This SOP is applicable for qualification of water system at ……………………. 3.0 RESPONSIBILITY: 3.1 Engineering officer/executive will be responsible to run the system efficiently and to regenerate and sanitize ...

1.0 OBJECTIVE: To lay down the procedure for the operation of nitrogen plant. 2.0 SCOPE: This Standard Operating Procedure shall be applicable at formulation plant of ……………… 3.0 RESPONSIBILITY: Operator/Technician-Engineering shall be responsible for attending the minor, major breakdown maintenance ...

One major benefit that computer systems have on the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records which are easier to process, store, and retrieve. Due to the advancement of information technology, management of health records has become very easy. ...

1.0 OBJECTIVE: To lay down the procedure for the operation and cleaning of Vernier Caliper. 2.0 SCOPE: This procedure is applicable to the operation and cleaning of Vernier Caliper used in production department. 3.0 RESPONSIBILITY: Production: Technical Associate/Officer /Executive/Assistant Manager Head ...