All Posts - Pharma Egg

Feb122022 by KBS.No Comments

Handling of Controlled Items in Production Area SOP

Production

Handling of Controlled Items in Production Area is prepared for the Production area of pharmaceuticals factory. Handling of Controlled Items in Production Area OBJECTIVE 1.1 To lay down the procedure for handling of controlled items in the production area. SCOPE 2.1 The scope of this SOP pertains to the handling of controlled items in the tablet section of the production area. RESPONSIBILITIES 3.1 It is the responsibility of Supervisor (Tablet) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (Tablet) to ensure that this procedure is followed in its entirety. 3.3 It is the responsibility of QAO to verify that this SOP is properly followed in its entirety. 3.4 It is the responsibility of Production Manager to make certain that thi...

Feb122022 by KBS.No Comments

Cleaning of Equipments and Accessories in Production Area

Production

Cleaning of Equipments and Accessories is laydown for Cleaning of production Equipment and accessories after the process of manufacturing in Pharmaceuticals. Cleaning of Equipments and Accessories OBJECTIVE 1.1 To describe the cleaning procedure for equipments and accessories. Cleaning of Equipments and Accessories SCOPE 2.1 The scope of this SOP pertains to cleaning of equipments and accessories placed in tablet section of production area. RESPONSIBILITIES 3.1 It is the responsibility of Operator and section Supervisor (Tablet) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (Tablet) to ensure that this SOP is followed in its entirety. 3.3 It is the responsibility of Production Manager to make certain that this SOP is followed in its ...

Feb122022 by KBS.2 Comments

Identification and Traceability SOP

Production

Identification and Traceability SOP is createdd to identity and trace production and process during and after manufacturing. Identification and Traceability PURPOSE: The purpose of this SOP is to design a system for assigning a unique number for Identification and Traceability. SCOPE: This SOP of Identification and Traceabilitycovers the identification and traceability of all Raw Materials, Packaging Materials, and Finished Products. RESPONSIBILITY: 1) Raw Material Store Supervisor is responsible to follow this SOP in assigning Identification Number to Raw Materials, received in store. 2) Packaging Material Store Supervisor is responsible to follow this SOP in assigning Identification Numbers to Packaging Materials, received in the store. 3) Production Manager is responsible ...

Feb122022 by KBS.No Comments

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...

Feb92022 by KBS.No Comments

Determination of Chlorpheniramine Maleate Raw Material

Testing Methods, Raw Material

Chlorpheniramine Maleate Testing Procedures and specification & analysis prescribes the requirements for Determination of Chlorpheniramine Maleate Raw Material, which is one of the components Alternate Method of Analysis on UV System and Other Testing procedures. 1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Chlorpheniramine Maleate, which is one of the components Syrup and Tablet. 2.0 SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES USP/BP/BP/Inhouse 4.0 DEFINITIONS Follow the SOPs 5.0 SPECIFICATIONS USP/BP/BP/Inhouse PHYSICAL ANALYSIS Physical Form Crystalline Powder Colour White Odour...

Feb92022 by KBS.No Comments

How To Test Cephradine L-Arginine Raw Material

Testing Methods, Raw Material

How To Test Cephradine L-Arginine 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 Cephradine L-Arginine Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cephradine L-Arginine Raw Material (Sterile) which is used in Injection. SCOPE How To Test Cephradine L-Arginine Raw Material is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse/ACS DOBFAR s.p.a of How To Test Cephradine L-Arginine Raw Material. DEFINITIONS Follow How To Test Cephradine L-Arginine Raw Mate...

Feb82022 by KBS.No Comments

Celecoxib Raw Material Testing

Testing Methods, Raw Material

Celecoxib Raw Material Testing. In this post, we share Celecoxib Raw Material Testing. You may also check our other Testing procedures here. 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Celecoxib, which is one of the components of Capsule. 2.0 SCOPE 2.1 It is applicable in Materials, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES Martindale / Manufacturer Specification 4.0 DEFINATIONS Company Quality Manual 5.0 SPECIFICATIONS Manufacturer Specification PHYSICAL ANALYSIS 1 Physical Form Fine powder 2 Colour White to Off-White 3 Solubility Soluble in Methanol 4 Melting Point 158°C to 162°C 5 Loss on Drying Note more than 0.5 % CHEMICAL ANALYS...

Feb42022 by KBS.No Comments

Cefuroxime Axetil Raw Material Testing Procedure

Testing Methods, Raw Material

As we know Cefuroxime is used to treat a variety of bacterial infections. This drug is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It does not work for viral infections (like cold, flu). In this post, we are going to share Cefuroxime Axetil Raw Material Testing Procedure. You may also check our other Testing procedures here Here is the complete process of Cefuroxime Axetil Raw Material Testing with steps 1.0 PURPOSE It is established to describe the specification and analysis of Cefuroxime Axetil Crystalline Special, which is one of the components of Suspension. 2.0 SCOPE It is applicable in the Materials, Product Development and Quality Assurance Department to confirm its physical and chemical ...

Feb42022 by KBS.No Comments

Ceftriaxone Sodium Sterile Raw Material Testing

Raw Material, Testing Methods

Ceftriaxone Sodium Sterile Raw Material Testing 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Ceftriaxone Sodium Sterile, which is one of the components of Injection. 2.0 SCOPE 2.1 It is applicable in materials, Product Development and Quality Assurance Department to confirm its Physical and Chemical specifications. 2.2 Item Code No..... 3.0 REFERENCES BP/USP/Martindale 31st Edition /Merck Index 12th Edition/ In-house 4.0 DEFINITIONS Company Quality Manual 5.0 SPECIFICATIONS Reference Martindale 31st Edition /USP/ Merck Index/ In-house Specifications. TESTS AND SPECIFICATIONS PHYSICAL ANALYSIS 1. Physical: Form Crystalline Powder 2. Colour: Almost white to yellowish 3. Color after reconstitution: Light yellow 4. Reconst...

Feb32022 by KBS.No Comments

How to Test Cefotaxime Sodium

Testing Methods, Raw Material

Testing Procedure Cefotaxime Sodium 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Cefotaxime Sodium (Sterile) which is used in Injection. 2.0 SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES USP/BP/USP 4.0 DEFINITIONS Follow Sop 5.0 SPECIFICATIONS USP/BP/USP PHYSICAL ANALYSIS 1 Physical Form Fine Powder 2 Colour Off White 3 Reconstitution Time Not more than 1 minute 5 pH After Reconstitution 4.5 to 6.5 at 25°C +- 2° 6 Moisture Contents Not more than 5% 7 Reconstitution 2.1 ml +- 0.1 ml 8 Clarity Clear without any visible contamination CHEMICAL ANALYSIS 9 Identification of Cefotaxime Sodium examinat...