Tag: DJIBOUTI

SOP on Operation, Calibration, Cleaning and Maintenance of LAF

April 8, 2022August 20, 2024 Anshu Rani

SOP on Functioning, Calibration, Cleaning, and Maintenance of LAF Objective: Technique for functioning, Calibration, Cleaning, and Maintenance of LAF. Scope: This SOP is relevant for the Operation, Calibration, Cleaning, and Maintenance of LAF in the Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control. Procedure: …

Microbiology

SOP on Maintenance and usage of Reference cultures

March 25, 2022February 26, 2024 Abha Maurya

SOP on Maintenance and usage of Reference cultures Objective: SOP on Maintenance and usage of Reference cultures. Responsibility: Officer or above of Microbiology Laboratory: Accountability: Head – Microbiology section. Head – Quality control. Procedure Procurement of Lyophilized Cultures Reference Cultures can be procured from following suppliers: ATCC: American Type Culture Collection, 10801, University Bivd, Manassas,…

Uncategorized

PRODUCT RECALL AND MOCK RECALL PROCEDURE

March 24, 2022November 16, 2024 Pharmaceutical Guidanace

PRODUCT RECALL AND MOCK RECALL PROCEDURE A product recall may be defined as the retrieval from the marketplace of a batch (es) of a medicinal product as a result of a quality defect or other issue being identified with the batch (es) which resulted in the batch (est.) not to be in compliance with the…

Quality Assurance

Rubber Bung Processor Cum Sterilizer

March 7, 2022January 28, 2024 Abha Maurya

Rubber Bung Processor Cum Sterilizer • HPHV Steam Sterilizer is used for sterilization of liquid, Hard and Hard Porous Material, Glass ware, drugs and surgical instrument used a pharmaceutical. It is also used For Sterilization of containers, vessels, linen, rubber articles culture media etc. • Provide with Sliding doors with high temperature resistant silicone gaskets….

Production

Cleaning of Factory Footwear

March 2, 2022January 28, 2024 Abha Maurya

Cleaning of Factory Footwear Objective To lay down a procedure for Cleaning of Factory Footwear. Scope This Standard Operating Procedure is applicable for cleaning of factory footwear in the formulation plant. Responsibility Housekeeping personnel is responsible to follow the procedure mentioned in SOP. HR Department is responsible for implementation of the procedure mentioned in SOP….

Production

SOP on Document Management System in Quality Assurance Department.

February 25, 2022January 28, 2024 Pharmaceutical Guidanace

Objective: To lay down a procedure for the Management of Documents in the Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Manager Q.A. is accountable for the compliance of this SOP. Procedure: Storage of Documents in Record Room. Documents shall be stored in the record…

Quality Assurance

Sterilization Process Controls

February 23, 2022January 28, 2024 Abha Maurya

Sterilization Process Controls Inspectional Objectives Confirm that the sterilization process was validated by reviewing the validation study. Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored. If review of the Device History Records (including process control and monitoring…

Production

Dry Powder Injection

February 13, 2022January 28, 2024 Abha Maurya

Dry Powder Injection Majority of drugs show the problem of poor solubility, whether in the case of their analytical estimations or in the field of liquid dosage forms in the form of solutions. Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs include methanol, ethanol, chloroform, benzene, dichloromethane, dimethyl formamide, acetonitrile, ethyl acetate,…

Key Point of Dry Powder Injection

February 12, 2022January 28, 2024 Abha Maurya

The injectable dry filling area is a completely sterile area of the company that is a strictly controlled area. The high-level alertness is mandatory to main the atmospheric condition in the filling area of the dry powder filling area of Injectable. Every step in the production area requires a written SOP. It is very important…

Production

DOCUMENTATION IN PHARMA

February 8, 2022January 28, 2024 Abha Maurya

DOCUMENTATION IN PHARMA Well-established documentation system exists to implement Good Documentation Practices, which is a part of Quality Assurance. Clearly written documents are prepared, reviewed and controlled, which prevents the errors from verbal communication and permits traceability for all activities carried out. Quality Assurance is responsible for the revision and distribution of documents and concerned…

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Quality Assurance

WATER SYSTEM

February 8, 2022January 28, 2024 Abha Maurya

WATER SYSTEM: A purified Water system is a basic requirement for Pharmaceutical Industries. Raw Water sourced from industry bore well water is converted into purified water complying with current USP/ BP/ IP/ Ph. Eur. GENERATION OF PURIFIED WATER: The raw water passes through a sand filter through a transfer pump. This will remove solid particles…

HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMS

February 8, 2022January 28, 2024 Abha Maurya

BRIEF DESCRIPTION OF HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SYSTEMS: To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference of the manufacturing areas with Air handling Units, Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained within the limits as per…

Engineering

BATCH MANUFACTURING RECORD OF DRY INJECTION

February 6, 2022January 28, 2024 Abha Maurya

BATCH MANUFACTURING RECORD OF DRY INJECTION Table of content Batch Details General Instructions Calculation of API Dispensing of raw material API transfer record Dispensing of primary packing materials Component preparation for sterilization Steam sterilization record Vial de-boxing, Staging, and Inspection record Vial washing record Vial depyrogenation record API Canister weight checking records Vial filling record…

Production

SOP on Handling of Out of Specification (OOS)

January 31, 2022November 16, 2024 Abha Maurya

SOP on Handling of Out of Specification (OOS)

Quality Assurance

Quality Risk Management in Analytical Laboratory

January 16, 2022January 28, 2024 Abha Maurya

Quality Risk Management in Analytical Laboratory The Quality of the Product Drugs or Drug Product is evaluated in Quality Control analytical laboratories, So It is important to understand that the “services” and “output” of a Quality Control / Analytical Laboratory is directly related to Safety, Identity, Strength, Purity (efficacy), Quality of a Drug Product, and…

Quality Control

Lyophilization of Parenteral

January 5, 2022January 28, 2024 Abha Maurya

Lyophilization of Parenteral Lyophilization or freeze-drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes: Freezing Primary drying…

Production

Equipment Qualification

December 27, 2021February 5, 2024 Pharmaceutical Guidanace

Equipment Qualification Manufacturers must establish a systematic approach to qualification and validation to guarantee the quality, safety, and effectiveness of their products throughout their lifecycle. It is crucial to employ statistical evaluation when necessary to provide scientific evidence that the processes, systems, or other relevant aspects are appropriately qualified or validated. The qualification and validation…

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Engineering

Flow Properties of Powders

December 25, 2021January 28, 2024 Pharmaceutical Guidanace

Flow Properties of Powders The use of powders in the pharmaceutical industry has generated a variety of methods for characterizing powder flow. Not surprisingly, scores of references appear in the pharmaceutical literature, attempting to correlate the various measures of powder flow to manufacturing properties. The development of such a variety of test methods was inevitable;…

Production

IMPURITIES IN NEW DRUG SUBSTANCES

December 9, 2021January 28, 2024 Pharmaceutical Guidanace

IMPURITIES IN NEW DRUG SUBSTANCES To provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state Impurities in new drug substances are addressed from two perspectives: Chemistry Aspects include classification and identification of impurities, report…

Quality Control

Failure Mode Effect Analysis (Risk Assessment) Compression Stage

December 7, 2021January 28, 2024 Pharmaceutical Guidanace

Failure Mode Effect Analysis (Risk Assessment) Compression Stage For More Pharma Updates Visit -https://pharmaguidances.com

Uncategorized

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