Category: QMS

Pharmaceutical OOS Investigation Decision Support Tool

No Comments
| QMS, Quality Assurance

Purpose: This interactive decision matrix provides a structured, risk-based approach for evaluating Out-of-Specification (OOS) test results during pharmaceutical manufacturing investigations. The tool aligns with current FDA and MHRA regulatory requirements for OOS investigations and supports objective decision-making through weighted scoring criteria. Key Benefits: Standardizes investigation decisions, provides audit trail documentation, ensures regulatory compliance, reduces subjective bias, and […]

Read More »

HOSTING REMOTE INSPECTION AT PHARMACEUTICAL FACILITIES

2 Comments
| Audit, News Updates, QMS

Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart from the third-party services like calibration and annual maintenance also impacted due to […]

Read More »

WEB Presentation

No Comments
| Interview & Placement, News Updates, QMS

Web presentation is an innovative idea to share pharmaceutical Knowledge, following PPT’s are updated currently  1. QRM – On Quality Risk Management  2. Make your company presentation  3. A brief review on HVAC system [youtube=https://www.youtube.com/watch?v=3UQL-J2YedE&w=320&h=266] http://www.slideshare.net/PalashDas10/slideshelf

Read More »

Electronic Document Management System [EDMS]

1 Comment
| Drug regulatory and guidelines, QMS, Quality Assurance

Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were made in keeping with procedures and GMP expectations. Reports are yet another […]

Read More »

Data Integrity (Part-III) (Some Major Observations)

No Comments
| Drug regulatory and guidelines, QMS, Quality Assurance

Observation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, Quality Control (QC) […]

Read More »

Data Integrity Part-II (Laboratory)

No Comments
| Drug regulatory and guidelines, QMS, Quality Assurance

Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the […]

Read More »

Data Integrity -Part-I

No Comments
| Drug regulatory and guidelines, QMS

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it […]

Read More »

Management of Corrective and Preventive Action (CA-PA)

No Comments
| QMS, Quality Assurance

The concept of Corrective and Preventive Action (CAPA) has doesn’t specifically appear in the older version of Good Manufacturing Practices. CAPA seems to have become popular in the pharmaceutical industry because of its use with medical devices.[ISO 13495:2003 and the FDA’s 1996 Quality System Regulation (QSR) for medical devices, include CAPA. This requirement for medical […]

Read More »

Popular methods of Risk Assessment (Part-II)

28 Comments
| QMS, Quality Assurance

Fault tree analysis The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred […]

Read More »

Popular methods of Risk Assessment (Part I)

No Comments
| QMS, Quality Assurance

Failure Mode Effects Analysis (FMEA) Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” means the ways, or modes, in which something might fail.  Failures are any errors or defects, especially ones that affect […]

Read More »