SOP for Colony Counter is an essential step towards maintaining the Functioning and integrity of instruments used in the Pharmaceutical microbiology section. 1.0 Objective: To establish a written procedure for the operation and calibration of the Colony Counter. 2.0 Scope: This SOP covers the process of operating and calibrating the Colony Counter. 3.0 Responsibility: Microbiologist: … Read more
In the challenging field where healthcare and legal complexities clash, a Pharmaceutical Industry Lawyers job appears to be a vital source of guidance. By examining their various responsibilities, we will see how crucial these legal experts are in ensuring that the ethical, regulatory, and business aspects of the pharmaceutical industry are all aligned. Introduction: Pharmaceutical … Read more
1.0 Objective: This document summarizes the procedure for the recruitment of employees within the pharmaceutical industry. 2.0 Scope: This standard operating procedure applies specifically to the Human Resource Department of the pharmaceutical industry. 3.0 Responsibility: The Head of the Human Resource Department and the QA Head are accountable for ensuring compliance with this procedure. 4.0 … Read more
1.0 Objective: This SOP achieves operational qualifications and performance qualifications. 2.0 Aim: This Standard Operating Procedure serves as Preventive Maintenance of the D.M. Plant 3.0 Procedure for Preventive Maintenance of D.M. Plant 3.1 Conduct an annual inspection and replacement of all faulty components.3.2 Apply grease to bolts and nuts to prevent corrosion and facilitate easy … Read more
Standard operating procedure for Handling Chemicals used in Purified Water plants in pharmaceutical industries. 1.0 Objective: This SOP outlines the steps for effectively managing chemicals used in pharmaceuticals for purified water plants.2.0 Scope: This standard procedure applies to the handling of chemicals within the purified water plants at Pharmaceuticals.3.0 Responsibilities: Engineering, Purchase, Warehouse, QC DepartmentsAccountability: … Read more
Standard Operating Procedure on Withdrawal, Storage, Observation & Destruction of Control/Retention Sample in Pharmaceuticals. 1.0 Objective: This SOP applies to the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality control (R.M. Retention) in the pharmaceutical formulation plant. 2.0 Scope: This Standard Operating Procedure applies to the withdrawal, storage, … Read more
1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples. 2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples. 3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOPThe Assistant Manager QC and/or QA Manager are responsible for Overall compliance with … Read more
OBJECTIVE: To establish a procedure for action to be taken where critical parameters exceed acceptable limits within the purified water system. SCOPE: This Standard Operating Procedure applies to the generation and distribution of purified water systems. RESPONSIBILITY: Officer, Executive – Engineering Department.Head – Engineering Department for overall compliance to this SOP. ACCOUNTABILITY:Head of Engineering PROCEDURE: … Read more
Pharmaceutical incompatibility is defined as any unwanted interaction of two or more drugs that results in a significant change either in the physical, chemical, or therapeutic behavior of drugs. The change can also result in an undesirable product which might affect the safety, efficacy, appearance, and stability of the product. Incompatibility can occur during compounding, … Read more
Learn About Pharmaceutical Suspension- Classification, Composition, Theory, Formulation/Preparation, Evaluation, Types, Advantages, and Disadvantages. Definition: Pharmaceutical Suspension is a biphasic system that consists of solids finely dispersed into a liquid medium. It is a coarse dispersion in which the active ingredient as the internal phase is dispersed uniformly throughout the external phase with the help of … Read more
Name: How to Preparare and Standardization of 0.1 M Disodium Edetate (EDTA Ingredients : 1. Disodium Edetate. 2. Calcium Carbonate 3. Eriochrome black – T 4. Ammonia – Ammonium Chloride Buffer pH10 (Mix 5.4 grams of NH4Cl + 35 milliliters of 10M NH3 solution & dilute to 100 milliliters with water.) 5 Hydrochloric Acid. How … Read more
1.0 OBJECTIVE: To design, engineer, and supply of Electric Stacker (Model: Modal name) and provide assurance that the machine is manufactured as per the URS and complies with CE recommendations. 2.0 SCOPE: The scope of this qualification document is limited to the Design Qualification of the Electric Stacker (Model: Modal name) for “Company Name and … Read more
Aim: To provide Procedure on Operation And Calibration Of Karl Fischer Apparatus.Objective: This standard operating procedure explains how to use and calibrate the Karl Fischer apparatus.Responsibility: Chemist/Executive Q.C. for following this procedure.Accountability: The Manager of Quality Control is accountable for overall compliance with this SOP. Procedure: Cleaning Related SOP: SOP for Analysis and Release of … Read more
1.0 Aim: Procedure for Analysis and Release of Packaging Materials 2.0 Purpose: This standard operating procedure outlines the procedure for analyzing and releasing packaging materials at [company name]. 3.0 Scope: This procedure applies to the quality control laboratory and covers the analysis and release of packaging materials. 4.0 Responsibility:QC Analyst: Responsible for analyzing packaging materials.QC … Read more
Aim: To prepare and standardize 0.5 M sulfuric acid (0.5 M H2SO4). Principle: 1. This is carried out by aqueous acid-base titration based on a neutralization reaction. 2. This titration takes place between sulphuric acid (H2SO4) and sodium carbonate (Na2CO3). 3. Sodium carbonate, anhydrous is a primary standard substance that reacts with a secondary standard … Read more
Objective: The purpose of this experiment is to standardize 1.0 M Sulfuric Acid. Materials used for 1.0 M Sulfuric Acid: Equipment: Beaker, Funnel, Pipette, BuretteChemicals: H2SO4, Phenolphthalein solution, and Anhydrous sodium carbonate. Theory: Methyl orange is commonly used as an indicator in titrations. In an alkaline solution, methyl orange appears yellow and has the following … Read more