The Medical Device Regulation EU 2017/745 is a highly important document outlining the requirements for any medical device. Through this, you will be able to understand the key requirements within the Medical Device Regulation. Although the new device regulation of 2023 has also been introduced, you can read about it in a separate post. In … 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
Learn About the scope, responsibility, objective, acceptance criteria, Technical specification, Drawing, Checklist, Calibration, and Documents required for the Design Qualification Protocol of Purified Water Storage & Distribution System. DESIGN QUALIFICATION: NAME OF THE UTILITY / EQUIPMENT /SYSTEM / AREA Purified water Storage & Distribution System VENDOR’S NAME & ADDRESS — USER DEPARTMENT XYZ Pharmaceuticals DOCUMENT … Read more
Top Companies Medical Representative Interview Questions and Answers are prepared with the help of our experts who belong to the marketing and sales departments of top pharmaceutical companies in India and the USA. Getting a sales representative job is always a significant challenge for candidates. Providing the best answers is very important for securing selection … Read more
The pharmaceutical coating process is a very crucial stage, where highly trained operators and officers are required. Reply with stick answers to the questions are play a big role in your selection, So based on that our experienced team has prepared useful Coating Area Interview Questions and their Answers. Introduction to Pharma Tablet Coating Pharmaceutical … Read more
The medical writing field has vast opportunities for medical science graduates. To prepare literature, brochures, and medical data, generally, pharmaceutical companies, contract research, regulatory service providers, medical communication, publishing, medical or scientific, hospitals, and academic institutions employ medical writers. So based on that our expert prepared a list of Common Medical Writing Interview Questions with … Read more
GC is one of the most used techniques in different organizations including Pharmaceuticals. So, there is a lot to provide for these instruments. If you want to work with it and preparing for interview then these Gas Chromatography Interview Questions and Answers are prepared based on the previously asked questions in top companies. GC Related … Read more