Tag: Corrective actions

Poor communication between quality assurance and production teams.

March 14, 2025 Admin

Poor communication between quality assurance and production teams. Poor communication between quality assurance and production teams. Introduction: In pharmaceutical manufacturing, the synergy between quality assurance (QA) and production teams is pivotal for ensuring the safety, efficacy, and quality of products. However, poor communication between these departments can lead to significant challenges, including compliance risks, production…

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

Troubleshooting Cleaning Validation Failures in Multi-Product Facilities

March 11, 2025 Admin

Troubleshooting Cleaning Validation Failures in Multi-Product Facilities Troubleshooting Cleaning Validation Failures in Multi-Product Facilities Introduction: In the pharmaceutical industry, maintaining cleanliness in manufacturing facilities is paramount, particularly in multi-product facilities. Cleaning validation ensures that the cleaning process effectively removes residues of active pharmaceutical ingredients, excipients, and cleaning agents. This process is critical to prevent cross-contamination…

Solid Dosage form, Tablets

How are critical processes validated in compliance with Schedule M?

September 20, 2023September 11, 2023 Admin

Validation of Critical Processes in Compliance with Schedule M Validation of critical processes is an essential aspect of pharmaceutical manufacturing to ensure that these processes consistently produce products of the desired quality and meet regulatory requirements. In compliance with Schedule M of the Drugs and Cosmetics Rules in India, pharmaceutical manufacturers must perform process validation…

Schedule M

What are the specifications for starting materials in Schedule M?

September 19, 2023September 11, 2023 Admin

Specifications for Starting Materials in Schedule M Schedule M of the Drugs and Cosmetics Rules in India lays down specific specifications for starting materials used in pharmaceutical manufacturing. Starting materials are raw materials that undergo further processing to become active pharmaceutical ingredients (APIs) or excipients in the final pharmaceutical product. These specifications ensure the quality,…

Schedule M

Explain the guidelines for the preparation and storage of working standards under Schedule M.

September 18, 2023September 11, 2023 Admin

Guidelines for the Preparation and Storage of Working Standards under Schedule M Schedule M of the Drugs and Cosmetics Rules in India provides specific guidelines for the preparation and storage of working standards used in pharmaceutical quality control laboratories. Working standards are reference materials used for calibration and quality control testing to ensure accurate and…

Schedule M

What are the requirements for labeling and identification of raw materials as per Schedule M?

September 18, 2023September 11, 2023 Admin

Labeling and Identification Requirements for Raw Materials as per Schedule M Schedule M of the Drugs and Cosmetics Rules in India sets forth specific requirements for the labeling and identification of raw materials used in pharmaceutical manufacturing. The purpose of these requirements is to ensure that raw materials are correctly identified, traceable, and used appropriately…

Schedule M

How is the sampling and testing of raw materials conducted under Schedule M?

September 17, 2023September 11, 2023 Admin

Sampling and Testing of Raw Materials under Schedule M Schedule M of the Drugs and Cosmetics Rules in India lays down specific requirements for the sampling and testing of raw materials used in pharmaceutical manufacturing. The purpose of sampling and testing is to verify the identity, quality, and purity of raw materials to ensure that…

Schedule M

What are the guidelines for storage and handling of raw materials under Schedule M?

September 16, 2023September 11, 2023 Admin

Guidelines for Storage and Handling of Raw Materials under Schedule M Schedule M of the Drugs and Cosmetics Rules in India provides specific guidelines for the storage and handling of raw materials used in pharmaceutical manufacturing. These guidelines are crucial to ensure the quality, safety, and efficacy of the final pharmaceutical products. Here are the…

Schedule M

How is environmental control maintained in Schedule M compliant manufacturing premises?

September 15, 2023September 11, 2023 Admin

Maintaining Environmental Control in Schedule M Compliant Manufacturing Premises Environmental control is a crucial aspect of Schedule M compliant manufacturing premises. It involves maintaining appropriate conditions in the manufacturing area to ensure product quality, safety, and compliance with Good Manufacturing Practices (GMP). Here are some key measures for maintaining environmental control in Schedule M compliant…

Schedule M

What are the specifications for utilities (e.g., water, air) under Schedule M?

September 14, 2023September 11, 2023 Admin

Specifications for Utilities (e.g., water, air) under Schedule M Schedule M of the Drugs and Cosmetics Rules in India provides specific requirements and specifications for utilities, such as water and air, used in pharmaceutical manufacturing. These specifications are crucial to ensure that the utilities meet the necessary quality standards and do not adversely affect the…

Schedule M

What are the specifications and acceptance criteria for pharmaceutical products under GMP?

September 13, 2023September 11, 2023 Admin

Specifications and Acceptance Criteria for Pharmaceutical Products under GMP Good Manufacturing Practices (GMP) require pharmaceutical manufacturers to establish and adhere to specifications and acceptance criteria for their products. Specifications define the quality parameters that the pharmaceutical product must meet, and acceptance criteria are the predetermined limits within which the product must fall to be considered…

GMP Guidelines

Explain the process of batch record review and approval under GMP

September 12, 2023September 11, 2023 Admin

Batch Record Review and Approval Process under GMP Batch record review and approval is a critical step in the Good Manufacturing Practices (GMP) compliance process for pharmaceutical and medical device manufacturing. It involves a thorough examination of the batch records to ensure that all manufacturing and quality control activities were performed in accordance with established…

GMP Guidelines