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General Topics

Here you can read general topics related to Pharmaceuticals.

How to Test Cloxacillin Sodium

How to Test Cloxacillin Sodium

General Topics, Raw Material, Testing Methods
How To Test Cloxacillin Sodium Raw Material specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. How To Test Cloxacillin Sodium Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cloxacillin Sodium Raw Material which is used in Capsules. PURPOSE This raw material specification & analysis prescribes the requirements for Cloxacillin Sodium (Compacted) which is one of the component of Capsule. SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse DEFINITIONS Follow SOP pharmaegg.co...

Ciprofloxacin Hydrochloride Raw Material Testing

General Topics, Quality Control
In this post, we have explained how to perform testing Ciprofloxacin Hydrochloride Raw Material in pharmaceuticals. 1.0 PURPOSE It is established to describe specification and analysis of Ciprofloxacin Hydrochloride, which is one of the components of Tablet. 2.0 SCOPE It is applicable in Material, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES USP/BP/inhouse 4.0 DEFINITION Follow SOPs 5.0 SPECIFICATIONS USP/BP/inhouse PHYSICAL ANALYSIS Physical Form Crystalline powder Colour Faintly Yellow to light yellow pH 3.0—4.5 at 25°C ± 2°. Melting point Should be between 318—320°C. Moisture Content Should be between 4.7---6.7 %. Water Contents (by karl Fischer) Between 4.7 to 6.7% CHEMICAL A...

Insect And Rodent Control SOPs

General Topics, Production
To control insects in pharmaceuticals, this SOP is created Insect And Rodent Control SOPs, Insect and rodents are too much harmful in pharmaceuticals unit. 01 PURPOSE This procedure is established for control of insects and rodents in the plant. 02 SCOPE It is applicable in plant. 03 RESPONSIBILITIES A) It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 04 PROCEDURE 4.1 Chemicals required for insect control a) Insecticides b) Fumigants a) Insecticides: Insecticides are classified according to the type of action that results in destruction of the insects. Synthetic organic compound, a single material, produces insecticidal action in several ways. Certain materials are selected and used, howev...

Entry and Exit for Workers SOPs

General Topics, Production
Entry and Exit for Workers SOPs are created for the a standard Rules to followed by all the worker of pharmaceuticals factory. 1.0 OBJECTIVE 1.1 To describe the procedure for Plant entry/exit through Workers Entrance. 2.0 SCOPE The scope of this SOP pertains to both male and female workers entry or exit in Plant through Workers Entrance. 3.0 RESPONSIBILITIES 3.1 It is the responsibility of all male and female Workers to follow this SOP during Entry or Exit in Plant through Workers Entrance. 3.2 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 4.0 DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standard Operating Procedure 4.2 QC: Quality Control 4.3 QA: Quality Assurance 5.0 MATERIALS & EQUIPME...

Standard analytical Procedure of Sodium Chloride

General Topics
Standard analytical Procedure of Sodium Chloride Content 99.0 per cent to 100.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder or colourless crystals or white or almost white pearls. Solubility Freely soluble in water, practically insoluble in anhydrous ethanol. IDENTIFICATION A. It gives the reactions of chlorides. B. It gives the reactions of sodium. TESTS If the substance is in the form of pearls crush before use. Solution S Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100.0 mL with the same solvent. Appearance of solution Solution S is clear and colourless. Acidity or alkalinity To 20 mL of solution S add 0.1 mL of bromothymol bl...
Personnel Hygiene in Pharmaceuticals Industry SOPs

Personnel Hygiene in Pharmaceuticals Industry SOPs

General Topics, Quality Assurance
Personnel Hygiene in Pharmaceuticals Industry SOPs is created to improve personnel hygiene of the employees that work in the Pharmaceuticals Industry. 1. PURPOSE To improve and maintain the conditions of personnel hygiene of the employees according to regulatory authority requirements and international standards. 2. SCOPE This SOP applies to all employees entering the manufacturing and warehouse areas of Pharmaceuticals. 3. RESPONSIBILITY 3.1 HR Manager is responsible for initial and ongoing health examination of the employees. 3.2 Administration staff monitors personnel hygiene standards of all employees entering in process area and ensures that overall working environment of the company shall be as per SOP. 3.3 Department head / Section in-charge ensures observance of per...
Type of Pharmacist and Their Duties

Type of Pharmacist and Their Duties

General Topics
A pharmacist is described as a person who is professionally qualified to prepare, properties, effects, interactions, dispense,  console medicinal drugs. In this Blog post, we study about Type of Pharmacist and Their Duties. Type of Pharmacist and Their Duties Pharmacists provide pharmaceutical care to patients, as well as basic primary health care services. By using knowledge about the mechanism of drug action, pharmacists understand how they must be used to achieve maximum benefits, minimal side effects, and avoid drug interactions.  Pharmacists education or graduates to understand biochemical mechanisms and action of drugs, drug use, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. It is associated with anatomy, physiology and pathophysiolo...

Aspirin Raw Material Standard Analytical Procedure

General Topics, Raw Material, Testing Methods
Aspirin Raw Material Standard Analytical Procedure Practical aspects resulting from the implementation of the quality management system in companies in various fields (e.g., information for management of measurement equipment, standard operating procedures or dealing with deviations) allow to obtain a high-quality product. A fundamental role in the proper approach to the requirements imposed on companies in the pharmaceutical industry by the market is their compliance with ISO standards relating to quality management. Aspirin Raw Material Standard Analytical Procedure REFRENCE: BRITISH PHARMACOPOEIA 2020 APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Quality Control Manager Verified By: Quality Assurance ...

Installation Qualification of HPLC (High Performance Liquid Chromatography)

General Topics
In this blogpost we study about Installation Qualification of HPLC. All testing methods presented in this qualification protocol will be validated and confirmed in accordance with the approved procedure. The following signatures imply acceptance of the result. 1.0 Objective: Make sure the goods used for analyzes are determined in accordance with the claims, according to the requirements in accordance and regulatory measures. 2.0 SCOOP: This protocol applies to "DLC-20 HPLC" for the ability to the competence of the installation and input. 3.0 Reference Guide: 3.0 REFERENCES: Validation Manual/ Validation Master Plan. SOP for Equipment Qualification. Instrument’s User’s Manual. 4.0 users The following requires the following for the device: Bayless Karris: • Wavely: Up t...

Pharmaceuticals Quality Control Testing

General Topics
Pharmaceuticals Quality Control Laboratory has to perform various type of testing on-site or utilize services, the various studies and validations include: Potency Purity pH Antimicrobial effectiveness testing Microbial and fungal identification Dissolution Sterility testing Stability testing Endotoxin testing Biological testing (screenings, assays, SDS/PAGE) Preservation Uniformity