MACO Calculation
Maximum Allowable Carryover (MACO) shall be calculated based upon theses three criteria. Using Health Based Data Based on Therapeutic Daily Dose (TDD) Based on LD50…
Category: Pharma Industry Guidelines
SOP : Responsibilities of Quality Control Dept.
1.Objective : To define the responsibilities of Quality Control Department. 2. Scope : This procedure is applicable to all the personnel working in Quality Control…
SOP : Cleaning of Glassware
1.Objective : To lay down the procedure for Cleaning of Glassware used in laboratory. 2. Scope : This SOP provides general instructions for Cleaning of…
SOP-Responsibility of Quality Unit
1.Objective : To define the responsibilities of Quality Unit. 2. Scope: This procedure is applicable to all personnel working in Quality Unit. 3.Responsibilities : Quality…
Personal Protective Equipment (PPEs)- Safety Guideline
What is PPE? PPE can include items such as safety helmets, gloves, eye protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs, ear…
Dealing With Industrial Emergency Conditions-Safety Guidelines
This covers basic steps to handle emergencies in the workplace. These emergencies include accidental releases of toxic gases, chemical spills, fires, explosions, and bodily harm…
Process Performance Qualification Protocol/Process Validation Protocol
Process Performance Qualification Protocol Name of Product: Stage: Product Code: Plant: Sr. No. Table of Contents Page No. 1. Purpose 2. Scope 3.…
SOP of Control Sample Management
1.Objective : To lay down procedure for handling of Control Sample. Also known as Retention Sample or Reserved Sample. 2. Scope : This procedure…
USFDA New Data Integrity and Compliance Guideline
(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP)…
SOP -List of Stamps
Objective : To lay down procedure for usage of stamps for issuance of documents by QA. Scope : This procedure is applicable to all documents,…
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