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
A Non-Conformance Report is issued when anything deviates from the standard required parameters for a product or components during the inspection periods by the Quality department. On deviating from the process parameters, a Quality person issued a document known as a Non-Conformance Report. NCR Definition: A Non-Conformance Report is a document that is used to … Read more
Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more
Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the difference between Controlled documents and uncontrolled Documents used in the Pharmaceutical documents system. Types of Document Copies in Pharmaceuticals: Master Documents: The originally approved copy of a document Is marked as a “MASTER COPY” stamp … Read more
When the process of moving technology including (Chemicals, Production/ Manufacturing, Control, and drug product-related documents) from one place to another, so we can make the same good stuff every time, that’s called technology transfer. Below is the full Checklist of Technology Transfer For Sending the Plant. Project identification No. — Name of Product — Technology … Read more
Learn about Temperature Mapping of Storage Areas their Objective, Frequency, methodology, protocol, significance, Procedure, and Guidelines. Definition and significance: Definition: temperature mapping is a study in which it is ensured that the environmental condition of the studied area is uniform and well within the acceptance criteria Objectives: The objective of Temperature Mapping is to provide … Read more
Deviation from any process in pharmaceuticals can lead to a matter of investigation and root cause analysis. the manufacturer or responsible person shall be followed the following steps to do an investigation and root cause analysis by using corrective and preventive action. 1. Investigation/ Title for Root Cause Analysis: Start with the product’s name and … Read more
Way to Improve Investigation Report in Pharmaceuticals: It becomes very important for organizations to write an investigation report while getting any observations during routine audits or external audits. As before FDA had issued more than a hundred of 483 observations during the last few years. The organization gets a chance to comply with the observation … Read more
A deviation in pharmaceuticals may affect different areas including the materials, machines, and processes. the list of potential areas of deviation are: List of potential areas of deviations: Materials Equipment Process General practices documents practices test methods specifications Materials: Raw materials/components, as well as labeling and packaging components, must meet their quality specifications before their … Read more
The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. The success rate of an audit relies on multiple factors, some of the Audit Check List for Quality Assurance are described below: 1.0 Quality Assurance Department 1.1 Does the company have a later quality … Read more
Both humidity and relative humidity refer to the amount of water vapour in the air, however, they are not the same. Humidity is the absolute amount of water vapour in the air, whereas relative humidity is the amount of water vapour in the air in comparison to the maximum amount of water vapour the air might … Read more
Pharma SOPs is used as a tool for providing a proper and systematic way to follow all rules and regulation under controlled manners in pharmaceutical industries. The quality assurance department reviews all SOPs before the distribution to the department. Read here the list of all Quality Assurance SOPs. List of all SOPs Related to Quality … Read more
IPQA Person plays a very important role in the quality of drugs or products during manufacturing. She/ He is responsible for carrying out all the processes as per standard operating procedures during manufacturing to ensure quality. The line clearance stage is the very crucial stage before starting a product. So the role of the IPQA … Read more
Quality Assurance person shall ensure the following Checklist For BMR Release. The header section of the checklist must contain the Product brand name, Product Generic name, Batch Number, Batch size, BMR number, and QA release number. Checklist for BMR Release Note: The Footer section for the Checklist for BMR must be checked by and approved … Read more
Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction of a marketed product that the FDA considers to be in violation of GMP. The Recall does not include market withdrawals. Whereas for product Complaints is not good things. It shows customer dissatisfaction with the manufacturer’s … Read more
Pharmaceutical Sampling involves selecting a portion of a product for a specific purpose. The sample is a part of a material collected following a defined sampling procedure. A Sampling plan specifies the location, the number of units, the quantity of material to collect, and the associated acceptance criteria. The Sampling procedure contains all sampling operations … Read more