Revised schedule M 2023.

Dear friend's

Hope all of you are doing well....!

Schedule M has been received and notified on 28th December 2023. There are many changes as compare to previous version.

The revised schedule M is divided into thirteen parts.

In coming days I will provide the summary of these changes in this site for your easy reference.

This change impacts all the pharmaceutical manufacturing plants in India.

See you...

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Hold Time study for Pharmaceutical products

Introduction: Manufacture should ensure that the products they are manufacture are safe, effective and quality required for intended use. System should be in-place and in-use to ensure that the products manufactured as per validated process. As per Good manufacturing practices, manufacture should ensure that the dispensing raw materials and packing materials, intermediates products, bulk and finished product are stored under suitable conditions. Storage arrangement should be such which safeguard the subsequent processing, stability, safety, efficacy or quality of starting materials, intermediate products, and bulk drug prior to final packing. Maximum hold time should be established to ensure that intermediate and bulk product can be held without producing results outside the acceptance criteria for the quality of the material. Intermediate and bulk product should not be store beyond the established hold time. The choice of maximum hold time should be supported by relevant data. man...

Good Laboratory practices and Requirements of Premises and Equipment's.

Good Laboratory Practices and Requirement of premises and Equipment's General Requirements:- a) The laboratory or the the organization of which it is a part must be an entity that is legally authorized to function and can be held legally responsible. b) Management ensures that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements. c) The Quality manger shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensures the maintenance of documented quality systems as per quality manual. Premises:- a) The laboratory shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination. b) Wall, floor and ceilings ( interior surface) shall be smooth and free from cracks and permits easy cleani...

Training

Training Training is the process of learning the skills you need to do a particular job or activity: Training is important part of any industry to improve skill set of employee to increase productivity, and Quality. Similarly in pharmaceutical industry training is mandatory requirement is given in different GMP guidelines. Every organization provide training to all the employees irrespective of their qualification and skill. Below are some important requirements related to training given in guidelines: The manufacturer should provide training in accordance with a written programme for all personnel who work into manufacturing area, storage area or into control laboratory (including technical, maintenance and cleaning personnel) . Newly recruited personnel should receive training as per their duties assign to them. Approved training programmes should be available. Continuing training should also be given, and its practical effectiveness should be periodically assessed. All...

Pharma Quality Desk - PQD

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