Pharmaceutical Quality Assurance
In the pharmaceutical industry, it is critical to pay attention to the storage and distribution of products. Medicines need to be stored under very specific conditions to ensure they retain their quality. Different dosage forms m…
Definition A Validation Master Plan (VMP) is a document providing information about the company’s validation program. This document must contain details of the validation and the timeframes for the studies to be performed. Ther…
During the normal course of operations, it may become necessary to introduce changes in the process to improve the quality. Occasionally, new equipments or instruments may be installed, or there may be a change in the utility sys…
Validation can be done at different stages of the process. Accordingly, there are three main types of validation as follows: 1. Prospective Validation – done before the process commences 2. Concurrent Validation – done as the…
Pharmaceutical manufacturers have to make sure their validation program covers all the important areas of pharmaceutical processing. The major areas include: Equipment validation (also called qualification). Facilities and util…
Just as measuring instruments need to be calibrated, it is important to demonstrate that the equipment and utilities in a pharmaceutical company are appropriate for their intended use and to prove that they are performing as expe…
Even a small error during the manufacture, packing, or storage of a pharmaceutical product can severely impact the health of thousands of patients who consume it. This is the reason why regulatory bodies lay down stringent qualit…
Batches are released for distribution by the QC department only after thorough testing and approval. The warehousing department must maintain systematically systematic records of batches released for distribution. For every batch…
This comprises all the documents that form part of the company’s quality management system. This includes documents such as the quality policy, quality procedures, work instructions, and records. These documents are arranged in a…
A quality audit is an independent evaluation performed to review if activities are performed in a manner to complies with set objectives defined in the company’s quality system. In the pharmaceutical industry, audits are an effec…
The USFDA requires that the quality standards of each drug product must be evaluated at least once a year. Other regulatory bodies have similar requirements and these can be met through the performance of an annual Quality Review…
A standard operating procedure (SOP) is a written set of instructions describing step-wise how a routine activity is to be performed. When the SOP is followed exactly, it ensures consistency of the operation being performed exact…