Author: chandrasekhar Panda

User Requirement specification (URS) of Equipment’s in Pharmaceutical


User requirement specification (URS) is a list of all the requirements from the user, like equipment to be purchased. After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria. The user department will raise the indent for his requirement regarding machine equipment or … Continue reading User Requirement specification (URS) of Equipment’s in Pharmaceutical

Requirements for Good Documentation Practices (GDP)


Introduction :This chapter defines the requirements for good documentation practices which build a basic foundation for a good quality management system. Good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.Good documentation practices follow to protect the integrity … Continue reading Requirements for Good Documentation Practices (GDP)

Cleaning Validation in Pharmaceutical Industry


Guideline : Health Products and Food Branch Inspectorate  Cleaning Validation Guideline-   Health Canada. Definition: Cleaning Validation: Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing medicinal products. Types of contaminants Chemical - Residues of the previous productBiological - MicroorganismsPhysical    - Particulate matter Solubility of API shall … Continue reading Cleaning Validation in Pharmaceutical Industry

Guidelines for Pharmaceutical Stability Study


Definition : What is stability studies The ability of a pharmaceutical product to retain its physical and chemical properties within specified limits throughout its shelf life. Types of Stability Studies : Long term testing Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. Intermediate testing … Continue reading Guidelines for Pharmaceutical Stability Study

Vendor Management System in Pharmaceutical Industry


DEFINATION: New Vendor: Manufacturer identified by Formulation Development or purchase department as a manufacturer to supply of a specific material from a specific manufacturing site. Approved Vendor: Manufacturer of raw material, primary and printed packaging material, which has been approved by QA to supply a specific material from specific site, based on the satisfactory cGMP … Continue reading Vendor Management System in Pharmaceutical Industry

Quality Management System (QMS)Importance in Pharmaceutical Industry


What is Quality Management system : A Quality management system (QMS) is the core of any quality and compliance process. It is a regulatory requirement that the Food and Drug Administration (FDA) and other global regulatory bodies consider critical. An automated QMS system reduces audit time and findings and lowers the risk of product recalls. … Continue reading Quality Management System (QMS)Importance in Pharmaceutical Industry

Engineering  Department Responsibility in Pharmaceuticals


Below are the responsibilities of Engineering personnel in Pharmaceutical Industry (But not limited To) 1. To follow Good Engineering Practice. 2.Preparation and Review of departmental SOPs 3. Preparation and Review of PM schedule, checklist and attending breakdown. 4. Observation and Guideline in installation activities of new equipment's or projects at site. 5. Implementation of SAP 6. To review and undertake … Continue reading Engineering  Department Responsibility in Pharmaceuticals

Audit Trails Reviews for Data Integrity


Introduction : Annex 11 requires that audit trails are regularly reviewed to ensure data integrity. There are a significant amount of inconsistent interpretations about the requirement to regularly review audit trails. Some of the interpretations are that a periodic review of audit trails should be performed to ensure data integrity. Under a periodic review approach … Continue reading Audit Trails Reviews for Data Integrity