The ISO 14644‑1 standard (2015 edition) is the global benchmark for cleanroom air cleanliness, defining nine classes (ISO Class 1–9) based on airborne particle counts. Each class sets maximum concentrations of particles ≥0.1, 0.2, 0.3, 0.5, 1.0, or 5.0 μm in a cubic meter of air. In practice, lower class numbers mean cleaner environments. For example, ISO Class 5 (used in … Read more
Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more
Microbial testing of Non-Sterile Products: A Brief Overview of Pharmaceutical Microbiology Basics and History, Microbial Control Strategy, Risk Management for Non-Sterile Standards, and Testing and Acceptance Criteria for Non-Sterile Products. When examining the types of products that carry higher risks, sterile products require a complete absence of microorganisms. This is because they are typically administered … Read more
An uncontaminated environment is essential in pharmaceutical manufacture. Clean rooms created with strict ISO guidelines are engineered with the intent of reducing particulate and microbial contamination in drug manufacturing processes. However, microbial contamination may still be present owing to inadequate cooling, cleaning regimens, or even both. These controlled environments must comply with regulations which means … Read more
The WHO defines pharmacovigilance as “the science and actions connected to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problems.” These Pharmacovigilance Interview Questions/ Answers are prepared by experts from Cognizant, Accenture, Novartis, IQVIA, Sanofi-Aventis, Merck, Covance, Pfizer, TCS, Bioclinica, and Syneous Health. Pharmacovigilance Interview Questions for Fresher Wipro Pharmacovigilance interview … Read more
A Pharmaceutical product’s quality is characterized as being pure, accurately identifiable, effective, and safe to use. Patients and customers have a moral (and legal) right to demand high-quality pharmaceuticals. The warehouse is responsible for all incoming items (including labeling and packaging) as well as the release of finished products, therefore it plays an important role … Read more
Learn about Standard operating procedures for Controlling and Storage Reference standards including Objective, Scope, Responsibility, Procedure, Storage and handling of reference standards, and Precautions. 1.0 Objective: To provide a procedure for controlling and storage of reference standards. 2.0 Scope: This procedure shall apply to all the reference standards that are used for analysis. 3.0 Responsibility:3.1 … Read more
In a pharmaceutical company, we often need to conduct Performance Qualification. While performing Performance Qualification, we have to pay attention to many aspects, such as following and implementing each step of the process according to the protocol. Therefore, you can review each process and its steps listed below, which should be included in a protocol. … Read more
When defining someone’s position in regard to the management of the audit, roles and responsibilities are important of course, but they serve more benefits. It also aids in the productivity of the audit teams. Responsibilities in Audit are certain specific tasks and duties that are allocated to you, in this case, solely. In other words, … Read more
The Why-Why analysis is considered to be a problem-solving approach that is mainly incorporated within the pharmaceutical industry so as to get to the root of the problems. It is a basic technique in which the why is asked Frequently until the real problem is found. This applies to the why-why technique the root cause … Read more
In audit opening meeting our primary purpose shall be to confirm the audit plan and its arrangements. The opening meeting sometimes called a pre-audit conference or start-up meeting, is basically held at the location of the auditee. Good practice requires that the team of auditors arrive together at a set time. This meeting requires preparation … Read more
Medical Device Single Audit Program, in short form, is termed MDSAP. MDSAP enables the carrying out of one regulatory audit with respect to the quality management system of a medical device manufacturer. MDSAP is a process audit and product approval is still required which is country country-specific procedure. MDSAP has seven chapters and ninety tasks. … Read more
Are you looking for the documents required for medical devices? If yes, in this article, you will find a list of those documents, which will be very useful in the future. Let’s discuss each document in detail. Here are the detailed Documents required for Class A medical device as per CDSCO. Application for grant of … Read more
Here You will learn about Standard Operating Procedure for Operating and Cleaning of Dry Bath Incubator including their Purpose, Scope, Responsibilities, Procedure, Cleaning, Precautions, maintenance, and Various Records. Purpose: To establish a standard operating procedure for operating and cleaning of Dry BathIncubator used in Laboratory. To meet compliance with Good Laboratory Practices. Scope: This standard … Read more
Learn about Standard Operating procedure for the Water Purifier including their Scope, Purpose, Responsibility, Procedure, maintenance, calibration frequency, and Records used in various Industries and Pharmaceutical formulation Departments. Purpose: To establish SOP (Standard Operating Procedure) for a Water Purifier intended to keep Reverse Osmosis water purification system in functional mode, To keep Water Purifier ready … Read more
Standard Operation Procedure for Cleaning and Operation of Outside Micrometer in Pharmaceuticals. Purpose: To lay down a procedure for cleaning & operation of Outside Micrometer. Scope: This procedure is applicable for all Outside Micrometers used at our organization. Responsibility: Accountability: Quality Manager Procedure: Definition: Outside Micrometer (External Micrometer): It accurately measures the outside diameter, length, … Read more