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This blog is designed to share my knowledge of pharmaceutical standard operating procedures, validations, qualifications, Quality Management Systems etc,
British Pharmacopoeia 2023
2023-11-02 07:18
The BP 2023 complete package• Six-volume printed edition, including the BP (Veterinary) 2023• Single-user online licence• Single-user download for offline useBP 2023Available… Read More
Limit Test For Iron IP/BP/USP
2023-10-21 05:25
AS PER IPRequirements Nesselar’s cylinder, Measuring cylinder, Glass rod, Citric acid, Thioglycolic acid, Ammonia solution, Standard iron solutionSol… Read More
Limit Test For Chloride
2023-10-17 04:08
AS PER IPApparatus Required  Nessler cylinders  Glass rod  Stand  Chemicals Required   Dilute Nitric acid   Silver nitrate, 0.1MSo… Read More
2023-10-14 01:58
 AS PER IPRequirements:Nessler's cylinder, measuring cylinder, glass rod, potassium sulphate, standard solution, Hcl, barium sulphate reagent and distilled water10 ppm Sulfate Standard… Read More
2023-10-13 13:09
Most of the pycnometers have a given volume. This volume can change with the time and temperature and therefore needs to needs to be determined precisely for accurate density measurements.Th… Read More
2023-10-13 04:49
Requirements:Nesselar’s cylinder, measuring cylinder, glass rod, potassium sulphate, standard solution, Hcl, barium sulphate reagent and distilled water10 ppm Sulfate Standard Solution… Read More
Blender Capacity Calculation
2023-10-06 04:00
It’s essential to pick the right blender for blending the pharmaceutical ingredients. There are various types of blenders for different uses, and the choice is made based on the needs… Read More
Entry And Exit Of Aseptic Area
2023-10-05 10:18
Table of Contents 1.0 OBJECTIVE: 1.1 To lay down the procedure for the Entry and exit of aseptic area2.0 RESPONSIBILITY:2.1 All authorized personnel entering into aseptic area of pa… Read More
2023-10-05 04:36
The material hopper is an integral part of the feeding system. Typically, it is capable of holding approximately 5–10 kg of material. Low level sensors are mounted in the hopper t… Read More
Differential Pressures Importance In Pharma
2023-10-03 10:56
Differential pressure in pharmaceutical settings refers to the difference in pressure between two areas or zones within a controlled environment, such as a cleanroom or pharmaceutical manufa… Read More
Sterility Test Validation
2023-09-30 06:14
 PROTOCOL APPROVAL Signing of this approval page of protocol indicates agreement with the Testing approach described in this document. If any process, procedure changes protocol shall… Read More
2023-09-25 12:57
1.0 OBJECTIVE1.1 To lay down a procedure for handling and cleaning of standard weights.2.0 SCOPE2.1 This procedure is applicable to the Warehouse Department of  3.0 RESPONSIBILITY3.1 Wa… Read More
Mobile Phase Solvents In HPLC
2023-09-23 01:28
High-pressure liquid chromatography (HPLC) is one of the most used techniques the pharmaceutical and other chemical industries to separate, qualitate and quantitate the components of a mixtu… Read More
How To Clean Spectrophotometer Cuvettes
2023-09-22 13:38
Contaminated cells are the greatest single source of error in spectrophotometry. Cells should never be handled by the optical polished faces, and analysts should rinse off residual or spille… Read More
Capacity Calculation Of Coating Machine
2023-09-22 06:24
The working capacity of the coating pan machine is determined by the brim volume of the coating pan. Brim volume is the total volume of the water when the pan is fully filled at its current… Read More
Liquid Transfer Pump
2023-09-21 12:48
1.0 PurposeThe purpose of this SOP is to develop a standard procedure for operating the Liquid Transfer Pump.2.0 ScopeThis SOP is applicable to the Liquid transfer pump used in the liquid ma… Read More
Audit Trail SOP
2023-09-21 01:22
1.0 OBJECTIVE :SOP on the Audit trail in PharmaceuticalTo lay down the procedure for allocation of rights at each user level, creation of new users and projects for HPLC analysis and procedu… Read More
Indian Pharmacopoeia 2010
2023-09-20 06:05
The sixth edition of the Indian Pharmacopoeia (IP 2010) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfar… Read More
Tablet Tooling
2023-09-19 12:55
Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, c… Read More
Blister Defects And Remedies
2023-09-16 04:31
Following are the issues that are encountered during the blister packing process: Leak test failureWrinkle on BlisterCavities DefectsBlister Cavity stuck in forming PlateForming station doe… Read More
2023-09-15 12:47
1.0 Objective: To establish a procedure for sanitization of Seals 2.0 Scope: This procedure applies to the sanitization of Seals used in the Sterile production department.3.0… Read More
Decartoning Of Vials
2023-09-15 11:58
1.0 Purpose: To lay down a procedure for the operation of Box Cutting and Vial loading.2.0 Aim: This Standard Operating Procedure is applicable to the operation of Box Cutting and… Read More
Destruction Of Rejected Dies And Punches
2023-09-15 06:33
1.0 Objective: To establish a procedure for the destruction of rejected dies and punches.2.0 Scope: This procedure applies to the destruction of rejected dies and punches used in t… Read More
Procedure For Footwear Cleaning
2023-09-14 06:47
1.0 Objective: Establishing a Procedure for Footwear Cleaning2.0 Scope: This procedure is applicable to the cleaning of footwear within the production department.3.0 Responsibility… Read More
Dispensing Or Issuing Packaging Materials
2023-09-13 10:26
1. PurposeTo provide a standard operating procedure for dispensing or issuing Packaging Materials in the warehouse.2. ScopeThe scope of this SOP is applicable for dispensing or issuance of p… Read More
Reverse Laminar Air Flow (RLAF)
2023-09-13 03:47
 1. Purpose:To lay down a procedure for Operation and Cleaning of Reverse Laminar Air Flow (RLAF) and RLAF Filter.2. ScopeThe scope of this SOP is applicable for Operation and Cleaning… Read More
Peak Tailing - HPLC
2023-09-12 08:28
Peak distortions are a common and frustrating problem when performing chromatographic experiments, and peak tailing in high-performance liquid chromatography (HPLC) is one of the most freque… Read More
Assay Of Ammonium Chloride
2023-09-11 11:44
 AIM:To determine the percentage purity of given sample of ammonium chloride.REFERENCE:1. Indian Pharmacopoeia -1985, volume I,2. Practical pharmaceutical inorganic chemistry, Dr. G.Dev… Read More
2023-09-11 09:01
1. Purpose:To lay down a procedure for cleaning of dispensing and sampling room.2. ScopeThe scope of this SOP is applicable for cleaning of dispensing and sampling room in the warehouse at [… Read More
Bin Blender Operation
2023-09-11 04:17
1.0 Objective: To establish a procedure for the operation of the Bin Blender.2.0 Scope: This procedure applies to the Bin Blender located in the manufacturing area.3.0 Responsibili… Read More
2023-09-11 04:10
1.0 OBJECTIVE: To establish a standard procedure for operating the tablet inspection belt.2.0 SCOPE: This procedure applies to the operation of the tablet inspection belt in the pr… Read More
2023-09-09 09:50
High-performance liquid chromatography (HPLC) is a widely used analytical technique for separating and analyzing chemical compounds in various samples. The heart of an HPLC system is the chr… Read More
2023-09-09 04:11
Multimill Design Qualifications Content:ObjectiveScopeResponsibility (Client and manufacturer)URS (User Requirement Specification)Machine descriptionTechnical specificationDetails of Utiliti… Read More
Operation Of Paste Preparation Kettle
2023-09-08 04:22
Objective: The objective of this procedure is to establish guidelines for operating a paste preparation kettle effectively.Scope: This procedure applies to the operation of the pas… Read More
Operating The Strip Pack Machine
2023-09-08 03:53
1.0 Objective: To establish a procedure for operating the strip pack machine.2.0 Scope: This procedure is relevant to the operation of the strip pack machine within the production… Read More
Cleaning Of Strip Pack Machine
2023-09-08 03:49
1.0 Objective: To establish a process for cleaning the Strip Pack Machine.2.0 Scope: This procedure applies to the cleaning of the strip pack machine within the production departme… Read More
Return Of Excess Packing Material
2023-09-07 09:13
OBJECTIVE: The aim is to establish a procedure for the retrieval of excess packaging materials from the production department and their return to the stores.SCOPE: This standard op… Read More
Blister Pack Machine
2023-09-07 07:27
1.0 Objective: This document aims to establish the operational procedure for the Blister Pack Machine.2.0 Scope: The procedure outlined here applies specifically to the operation o… Read More
Weighing Of Sample On An Analytical Balance
2023-09-06 13:04
1.0 Purpose:To lay down a procedure for Weighing of Sample on an Analytical Balance.2.0 Scope:The scope of this procedure is applicable for Weighing of Sample on an Analytical Balance.3.0 Re… Read More
De-blistering Machine Operation
2023-09-06 03:51
1.0 Objective: This procedure establishes guidelines for the operation of the de-blistering machine.De blistering machine2.0 Scope: This procedure is applicable to the operation of the de-bl… Read More
Leak Test Of Packed Materials
2023-09-05 09:32
1.0 OBJECTIVETo provide a procedure for determining the Leak test of packed material.2.0 SCOPEThis SOP covers the Leak test of packed material.3.0 RESPONSIBILITYProduction Chemist4.0 ACCOUNT… Read More
Diluents And Fillers In Pharmaceuticals
2023-09-05 06:57
Diluents and fillers are a ubiquitous class of materials in formulated products, including pharmaceuticals, medical devices, vaccines, nutraceuticals, cosmetics and industrial goods. But wha… Read More
Bubble Point Testing
2023-09-04 13:00
Don protective safety glasses and examination gloves. Prepare the bubble point tester.Verify the air control valve is turned to OFF. Turn the pressure regulator knob fully counterc… Read More
SOP For Metal Detector / Deduster
2023-09-04 08:03
1.0   PURPOSE:The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum deduster.2.0   SCOPE:This SOP is ap… Read More
SOP For Acceptance Quality Level(AQL)
2023-09-04 03:28
1.0  OBJECTIVE  To lay down the procedure for the visual inspection and statistical evaluation of  a batch ( Acceptance Quality Level).2.0 SCOPEThis procedure is applicab… Read More
SOP On Operation Of Colloid Mill
2023-09-04 01:50
The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for operation of colloid mill.This procedure is applicable to operation of colloid mill at manufacturing fac… Read More
SOP For Handling Punches And Dies
2023-09-04 01:42
Objective:The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for handling and control of punches and dies, used during compression.Scope: This procedure i… Read More
Moisture Balance Operation And Calibration
2023-09-02 13:22
PURPOSE: The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for operation of moisture balance.SCOPE:This procedure is applicable for moisture balance in m… Read More
Metal Detector And Challenge Test
2023-09-02 13:10
The presence of metal pieces even in trace quantity may degrade drugs, medicine and nutrients. For example, Vitamin-C i.e. ascorbic acid and chemically known as L-3-keto-threo-hexuronic acid… Read More
Prescott's Microbiology
2023-09-02 11:13
The author team of Prescott’s Microbiology continues the tradition of past editions by providing a balanced, comprehensive introduction to all major areas of microbiology. This balance… Read More
2023-09-02 04:13
Our knowledge about microbiology and immunology is constantly growing, and by building a good foundation of understanding in the beginning, it will be much easier to understand the advances… Read More
Pelczar Microbiology
2023-08-29 01:05
Microbiology is the study of living organisms of microscopic size, which include bacteria, fungi, algae, protozoa; and the infectious agents at the borderline of life that are called viruses… Read More
Pearson Guide To GPAT
2023-08-28 07:25
The Graduate Pharmacy Aptitude Test (GPAT) is an online national level examination for admission into all post graduate pharmacy programs approved and conducted by the All India Council for… Read More
GPAT Syllabus 2024
2023-08-28 01:36
GPAT Syllabus 2024: The All India Council for Technical Education (AICTE) prescribes the syllabus for the Graduate Pharmacy Admission Test (GPAT) for all pharmacy aspirants. Aspirants p… Read More
Social And Preventive Pharmacy
2023-08-28 01:07
Unit IHealth and Disease Concept Definitions assessment, definition as well as definitions of health for the public. Understanding the concept of prevention and treatment of diseases and hea… Read More
Biostatistics And Research Methodology
2023-08-26 03:48
 Unit-I Introduction: Statistics, Biostatistics, Frequency distribution. Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples. Measures of dispersion… Read More
Pharmacovigilance
2023-08-24 12:33
Unit-I Introduction to Pharmacovigilance History and development of Pharmacovigilance, Importance of safety monitoring of Medicine, WHO international drug monitoring programme, Pha… Read More
Pharma Marketing Management
2023-08-24 01:00
Unit-IMarketing: Definition, general concepts and scope of marketing, distinction between marketing & selling. Marketing environment. Industry and competitive analysis. Analyzing consume… Read More
Cosmetic Science
2023-08-23 01:03
UNIT I Classification of cosmetic and cosmeceutical products Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quas… Read More
2023-08-22 03:33
Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics and pharmacokinetics and their applications in pharmaceutical development, design of dose and dosage regime… Read More
Medicinal Chemistry -II
2023-08-21 03:36
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and therapeutic value of drugs. The subject emphasizes on structure activity relationships of drug… Read More
Pharmaceutical Biotechnology
2023-08-21 03:25
 SCOPE:  Biotechnology has a long promise to revolutionize the biological sciences and technology. Scientific application of biotechnology in the field of genetic e… Read More
Pharmaceutical Quality Assurance
2023-08-21 03:20
Scope: This course deals with the various aspects of quality control and quality assurance aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests, docu… Read More
2023-08-19 11:59
The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control durin… Read More
Pharmacology-III
2023-08-19 08:08
Scope: This subject is intended to impart the fundamental knowledge on various aspects (classification, mechanism of action, therapeutic effects, clinical uses, side effects and contraindica… Read More
2023-08-19 08:00
Scope: This subject gives the student the knowledge of basic understanding of herbal drug industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics, nat… Read More
2023-08-19 07:21
1.0 PURPOSE:To define procedures for housekeeping, cleanliness, and maintenance in the laboratory.2.0 SCOPE:This standard operating procedure provides the procedure for Good Document Practic… Read More
2023-08-19 05:09
 1.0 ObjectiveTo describe the procedure for identification of samples for repeat analysis and their acceptance criteria.2.0 ScopeThis procedure applicable to all bioassays for the estim… Read More

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