Tag: In-process controls

Poor standardization of in-process quality control procedures.

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Poor standardization of in-process quality control procedures. Poor standardization of in-process quality control procedures. Introduction: In the pharmaceutical industry, maintaining the highest quality standards is paramount. This is especially true for solid oral dosage forms, such as hard and soft gelatin capsules, where the absence of rigorous in-process quality control (IPQC) can lead to significant…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Explain Research and Development in Pharma.

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Research and Development in Pharma Research and Development (R&D) plays a critical role in the pharmaceutical industry, driving innovation and the discovery of new drugs and therapies. It is a dynamic and complex process that involves various stages of scientific exploration, preclinical testing, and clinical trials. 1. Drug Discovery Drug discovery is the initial phase…

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Pharma Research

What are the requirements for premises and equipment under Schedule M?

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Premises and Equipment Requirements in Pharmaceutical Manufacturing Let’s explore the specific requirements for premises and equipment under Schedule M: 1. Premises Requirements Under Schedule M, the manufacturing premises must meet specific criteria to ensure a controlled and suitable environment for drug production. The following are the key requirements for premises: Location: The manufacturing facility should…

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Schedule M

How is compliance with Schedule M ensured during drug manufacturing?

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Ensuring Compliance with Schedule M during Drug Manufacturing Schedule M lays down stringent guidelines and requirements to ensure the quality, safety, and efficacy of drugs produced in India. Manufacturers must adhere to these guidelines throughout the manufacturing process to maintain compliance. Let’s explore the key measures taken to ensure compliance with Schedule M during drug…

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Schedule M

What types of drugs and pharmaceuticals does Schedule M apply to?

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Types of Drugs and Pharmaceuticals Covered by Schedule M Schedule M, a crucial aspect of the regulatory framework under the Drugs and Cosmetics Act, 1940, applies to various types of drugs and pharmaceuticals. The following are the main categories of drugs and pharmaceuticals that fall under the purview of Schedule M: 1. Allopathic Medicines Schedule…

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Schedule M

What are the objectives of Schedule M?

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Unveiling the Objectives of Schedule M: Ensuring Quality and Safety in Pharmaceuticals Schedule M is a crucial part of the regulatory framework under the Drugs and Cosmetics Act, 1940, in India. Its objectives are designed to ensure the production of high-quality drugs and pharmaceuticals that meet strict standards of safety, efficacy, and quality control. Let’s…

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Schedule M

What is Schedule M under the Drugs and Cosmetics Act, 1940?

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Understanding Schedule M under the Drugs and Cosmetics Act, 1940 Schedule M is a crucial regulatory provision that governs the manufacturing and quality control of drugs and pharmaceuticals in India. Let’s delve deeper into what Schedule M entails: 1. What is Schedule M? Schedule M is a set of guidelines and requirements laid down by…

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Schedule M