Tag Archives: Highland

SOP on Document Management System in Quality Assurance Department.

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 …

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Sterilization Process Controls

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 …

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Dry Powder Injection

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, …

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Key Point of Dry Powder Injection

A 7 -

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 …

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DOCUMENTATION IN PHARMA

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 …

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WATER SYSTEM

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 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. …

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HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMS

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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 …

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BATCH MANUFACTURING RECORD OF DRY INJECTION

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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 …

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WHO TRS1019 Appendix 3 – Cleaning validation Principle

WHO TRS1019 Appendix 3 – Cleaning validation Principle Content of Cleaning validation Principle 1.0 Principle 2.0 Scope 3.0 General 4.0  Cleaning validation protocols and reports 4.1 Cleaning validation protocols 4.2 Cleaning validation reports 8.0 Personnel 6.0 Equipment 7.0 Detergents 8.0 Microbiology 9.0 Sampling 9.1 General 9.2 Direct surface sampling (direct …

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Quality Risk Management in Analytical Laboratory

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 …

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Lyophilization of Parenteral

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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 …

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Equipment Qualification

A 15 -

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 …

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Flow Properties of Powders

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 …

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IMPURITIES IN NEW DRUG SUBSTANCES

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 …

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Process validation scheme

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Process validation scheme Traditional process validation Where validation data on production-scale batches are not provided with the application and traditional process validation is proposed, the process validation scheme described below should be submitted by the applicant. This should outline the formal process validation studies to be conducted on production-scale batches …

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Process validation (Continuous process verification) for finished products

Process validation (Continuous process verification) for finished products Process validation can be defined as documented evidence that the process, operated within established parameters can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes (ICH Q7). Continuous process verification has been introduced to cover …

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Qualified Person

Qualified Persons A qualified person shall be in possession of a diploma, certificate, or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical …

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DRUG DESIGN (AN OVERVIEW)

DRUG DESIGN (AN OVERVIEW) DRUG DESIGN DRUG DESIGN Approaches to drug discovery: Serendipity (luck) Chemical Modification Screening Rational Irrational, based on serendipity & Intuition Trial & error approach in DRUG DESIGN Time consuming with low through output No de novo design, mostly  “Me Too Approach” First generation Rational approach in …

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CHANGE CONTROL

CHANGE CONTROL Change Control is “A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is …

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