Pharmaceutical Guidance Complete Pharma Solution

Technology Transfer in pharmaceutical manufacturing (WHO) Introduction Scope Glossary Organization and management Production: transfer (processing, packaging and cleaning) Quality control: analytical method transfer Premises and equipment Documentation Qualification and validation 1.1 Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, …

Process Validation Critical Parameters Process Validation(FDA Definition) Establishing Documented Evidence, Which provides a high degree of assurance that a specific process will  consistently produce a product meeting its predetermined specifications and quality attributes.” Steps in Validating a Process: Develop validation protocol Conduct installation qualification Conduct operational qualification Conduct performance qualification …

Equipment Status log OBJECTIVE: To lay down a procedure of the maintenance of equipment sequential log. SCOPE: This SOP is applicable to all equipment and machines of all manufacturing departments RESPONSIBILITY: Production and Engineering officer/above shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : Concerned Department Head and QA Head …

Cleaning of general item OBJECTIVE: To lay down a procedure to describe the steps to be followed for cleaning general items. SCOPE: Applicable for cleaning all HDPE / SS containers, utensils, scoops, sampling tools and different cleaning aids RESPONSIBILITY: Housekeeping workers, Production Supervisors, Operators, IPQA personnel shall be responsible to follow the …

NON-CONFORMANCE RESULTS OBJECTIVE: To lay down the procedure for define the necessary action against the non-conformance of a product. SCOPE: This procedure is applicable for information, investigation and control for any kind of non- conformance noticed or confirmed in Production, Stores on in others area for its proper investigation RESPONSIBILITY: Officer – …

Prevention and Product Mix Up OBJECTIVE:   To lay down the Procedure for prevention of Product mix-up. SCOPE: This procedure is applicable for the control and prevention of product mix up during and after the manufacturing of the product . RESPONSIBILITY: QA officer and Production Officer shall be responsible for the …

INTRODUCTION To establish inspection consistency and uniformity by discussing practices that has been found acceptable (or unacceptable). The cleaning validation – to validate the process and collect the scientific data that prove the system consistently does as expected and produce a result that consistently meets predetermined specifications. This guide is …

Non-sterile process validation Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available …

URS of De-Dusting Machine S. No. Table of Contents 1.0 General 2.0 Salient Features 3.0 Operational Requirements 4.0 Utilities 5.0 Maintenance 6.0 Commissioning and Documentation 7.0 Training 8.0 Packaging 9.0 Deviations 10.0 Delivery TECHNICAL  S. No. Parameters Required Specifications 1. 1.1 General Equipment No. 1.2 Description Portable unit for Tablets …

SOP on house keeping, cleaning and sanitization of general area in Pharmaceutical company. Objective :To lay down a procedure for Good House Keeping, cleaning and sanitization of General Area. Scope: This procedure is applicable for cleaning and sanitization of General areas other than manufacturing area of the Pharmaceutical Company. Responsibility: …

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to …

What are good documentation practices & how can they best be implemented? Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards …

Drug Master Files (DMFs) and it submission Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those …

Hydroxychloroquine and Antimalarial Drugs (united healthcare) These are antimalarial drugs found to induce remission in upto 50% patients of Rheumatoid Arthritis (RA), but take 3–6 months. Their advantage is relatively low toxicity, but efficacy is also low; bony erosions are not prevented. Their mechanism of action is not known, however, …

Characterization of Fine Particle in Formulation of drugs Parameters those are measured: (i) Particle size and size-distribution (ii) Shape of the particle (iii) Surface morphology of the particles (iii) Zeta potential Instrumental Methods of Particle Size Characterization: (i) Light Microscope: • First a standard graticule (BS 3625) is standardized with …

PROCESSING OF PARENTERAL PREPARATION Following steps are involved in the processing of parenteral preparation: 1. Cleaning of containers, closures and equipments. 2. Collection of materials. 3. Preparation of parenteral products. 4. Filtration. 5. Filling the preparation in final container. 6. Sealing the container. 7. Sterilization 8. Evaluation of the parenteral …

Formulation of Suspensions Biphasic liquids such as suspensions and emulsions are unique dosage forms because many of their properties are due to the presence of a boundary region between two phases. In suspensions, a liquid and an insoluble solid meet to form an interface. In the case of emulsions, two …