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 →

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 →

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 →

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 →

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 →

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 →

1.         OBJECTIVE              To laydown a procedure for the cleaning, storage, usage and maintenance of packing machine change parts. 2.         RESPONSIBILITY    Technical Assistant – Cleaning/storage/Maintenance of packing machine change Parts. Executive  – Responsible for Cleaning/storage/Maintenance of packing  machine change parts. 3.         PROCEDURE                        CLEANING 3.1.1    Dismantle the change parts from the machine. 3.1.2 Clean the change parts, using lint … Continue reading Procedure for the cleaning, storage, usage and maintenance of packing machine change parts →

  1.0     OBJECTIVE              1.1       To lay down a procedure for Preventive Maintenance of Auto Coater.   2.0     RESPONSIBILITY                                                   All Tec. Assistants - To perform the preventive maintenance activities as per the respective SOP. All Executives (Eng.Dept.) – To prepare and comply the preventive maintenance SOP. All Department Heads – To implement and compliance of this … Continue reading Preventive Maintenance of Auto Coater →

1.         OBJECTIVE              1.1       To lay down the procedure for Preventive Maintenance of Autoclave 2.         RESPONSIBILITY                                                   Assistant - Engineering &Production  - To follow the SOP Executive - Engineering & Production - To comply the SOP 3.         PROCEDURE 3.1       Monthly Maintenance 3.1.1     Check the Oil level in the FRL unit assembly and refill the oil with … Continue reading Preventive Maintenance of HPHV Autoclave →