Charging of plastic granules PURPOSE To lay down the procedure of charging of plastic granules in FFS machine. 2.0 SCOPE This SOP is applicable for charging of plastic granules in FFS machine at SVP section 3.0 REFERENCE(S) & ATTACHMENTS 3.1 References 3.1.1 In-House 3.2 Attachments 3.2.1 Attachment: I Granule Tank cleaning record 4.0 RESPONSIBILITY:…
Operation & Calibration of Conductivity meter 1.0 PURPOSE: To lay down the procedure for operation & calibration of conductivity meter. 2.0 SCOPE : 2.1 This SOP is applicable for production department (SVP) for Operation and calibration of Conductivity meter. Make Modal Eutech CON 700 3.0 REFERENCE(S) & ATTACHMENTS: 3.1 References 3.1.1 In House…
BATCH PREPARATION OF SVP PRODUCTS 1.0 PURPOSE To establish the written procedure for batch preparation of SVP products. 2.0 SCOPE This SOP shall be applicable for batch preparation of SVP products at SVP section 3.0 REFERENCE(S) & ATTACHMENT(S) 3.1 REFERENCE(S) 3.1.1. USP <797> Pharmaceutical compounding sterile preparation. 3.1.2. PIC/S “guide to GMP…
Area cleaning and sanitization PURPOSE : To define procedure for cleaning of production and other adjacent area. SCOPE : This SOP applicable for cleaning and sanitization of furniture, fixture, floor, walls, trolley etc. REFERENCE(S) & ATTACHMENTS : 3.1 References In House 3.2 Attachments 3.8.1 Attachment -I : Daily cleaning record 3.8.2 Attachment-II : Approved disinfectants/cleaning…
PROCEDURE FOR AGREEMENTS/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES AGREEMENTS Service Provider: A service provider is an organization or an individual who provides professional or expert advice/ service in a particular element of pharmaceutical Quality Service provider can be a Subject Matter Expert and/or a consultant. etc. Technical Team Technical team shall comprise of personnel from…
Guideline for Process Validation To define the procedure for exhibit batch monitoring and process validation of drug products for meeting all the predefined attributes and the process is capable of consistently delivering quality products. This involves the collection and evaluation of data from the process design stage through commercial production to establish scientific evidence that…
GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance In the complex and dynamic world of pharmaceuticals, ensuring the quality, safety, and compliance of products is of paramount importance. GxP, a set of regulations and guidelines that govern various aspects of pharmaceutical manufacturing, plays a critical role in maintaining industry standards. This blog explores the significance…
Read More “GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance” »
Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in formal stability studies? A: The…
Stability (ICH) Quiz 6 [ays_quiz id=’12’]
Stability (ICH) Quiz 5 [ays_quiz id=’11’]
Stability (ICH) Quiz 4 [ays_quiz id=’10’]
Stability (ICH) Quiz 3 [ays_quiz id=’9′]
Stability (ICH) Quiz 2 [ays_quiz id=’8′]
Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance or drug product across the…
Production Quiz 02 Question: What is mottling, and what factors contribute to this defect in tablets? Answer: Mottling is a tablet defect that can be caused by colored drugs (Excipient-related), improper mixing of granular material (Process-related), dirt in the granular material, or the use of oily lubricant, leading to oil spots. Answer: How does the…
Quality Control Quiz 1 [ays_quiz id=’5′]
Production Quiz 01 Question: What are the challenges faced in tablet manufacturing? Answer: The challenges in tablet manufacturing include visual and functional defects, which have increased due to complexities in tablet presses and higher quality demands. Question: Why have advancements and innovations in tablet manufacture not decreased the production problems? Answer: The production problems have…
Quality Risk Management -Questions and answers Q1: What is the purpose of Quality Risk Management in the context of medicinal products? A1: Quality Risk Management serves as a systematic process for assessing, controlling, communicating, and reviewing risks related to the quality of medicinal products. It encompasses both proactive and retrospective approaches. Q2: What are the…
Read More “Quality Risk Management -Questions and answers” »
Quality Control Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until…
Pharmaceutical Quality System Pharmaceutical Quality System – Questions and answers Q1: What is the main goal of a Pharmaceutical Quality System for medicinal product manufacturing? A1: The primary goal of a Pharmaceutical Quality System is to ensure the consistent delivery of medicinal products with appropriate quality attributes through the entire product lifecycle. Q2: How is…
Read More “Pharmaceutical Quality System – Questions and answers” »
