Pharmaceutical Guidelines

SOP for Reduced Testing Standard operating procedure to reduce the testing of raw materials to increase the speed of testing and productivity of quality control department. 1.0 PURPOSE To define the procedure for releasing the materials after reduced testing. 2.0 SCOPE This procedure is applicable to raw material testing carried out in quality control. 3.0 RESPONSIBILITIES 3.1 Analyst 3.1.1 To check the integrity of the consignment at the time of sampling. 3.1.2 To ensure approved COA of the manufacturer should available. 3.1.3 To carry out reduce testing as per SOP. 4.0 ACCOUNTABILITY 4.1 Head QC or Designee 4.1.1 To ensure the documentation as per SOP. 4.1.2 To ensure that analysis carried out as per SOP while apply the reduce testing. 5.0 PROCEDURE 5.1 Same Batch 5.1.1 If the material of the same batch no. received within two months from the same manufacturer, the analyst shall check the integrity of thecontainer, approved COA of the manufacturer, and other details as per the GIM ag...

SOP for Password Policy and Data Backup and Storage for Computer Systems Standard operating procedure for computer system passwords and data backup and storage. 1.0 PURPOSE To lay down the procedure for password and data backup policy for computerized systems. 2.0 SCOPE This SOP shall be applicable for the instruments/ equipment wherein data is generated and stored in the computerized systems in the facility. 3.0 RESPONSIBILITY Officers/ Executive 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE System, Password and Back-up policies for various instruments/ software shall be followed as the below-mentioned procedure. 5.1 Password Policy 5.1.1 Each user shall have unique Username and Password. 5.1.2 Password validity shall be 30 Days. 5.1.3 Password shall have at least 8 characters. 5.1.4 System shall not acquire last 5 expired passwords. 5.1.5 Account shall be lockout automatically after 5 wrong login attempts. Lockout of user shall be unlocked only by administrator. 5.2 User Managemen...

What is Delay Volume in HPLC? : Delay volume, dead volume, dwell volume and void volume are well know terms in HPLC analysis. These are useful for an accurate analysis of pharmaceutical products  by HPLC. The delay volume in HPLC is often a topic where most people not only industry specialists in analytical chemistry but also other unrelated spheres  seek clarification or seek to understand what it entails. This article, therefore, is aimed at enlightening anyone in need of having a solid understanding  of the concept be it in the pharmaceutical aspect or the general public intending to have a basic understanding of the idea for knowledge purposes. Giving a concise and clear explanation of the delay volume in HPLC, therefore, will leave everyone who reads the article with a satisfactory and  candid comprehension of the concept. HPLC is an abbreviation for high-performance liquid chromatography. It is a technique used in analytical chemistry to separate, quantify and ...

Theoretical Plates 'N' and their Determination in HPLC Analysis Learn about the theoretical plates N and their calculation in HPLC using the retention time and peak width. This is a helpful parameter to determine the system suitability. Theoretical plates are known as a measuring tool of HPLC column efficiency . Any chromatography column doesn't have any physical plate but it is a result of a mathematical calculation. The columns having a high number of theoretical plates are considered more efficient in HPLC separation than the columns having less number of theoretical plates. A more efficient HPLC column will have a narrower peak than a less efficient column with less theoretical plates at the same retention time. Related: Principle of HPLC High column efficiency is needed to resolve the narrow peaks in the drug analysis. Hence the resolution of peaks also depends upon the column efficiency i.e. theoretical plates. Theoretical plates are calculated per meter length of the...

System Suitability in HPLC Analysis System suitability is to prove that system is working perfectly before the analysis on HPLC, GC, TOC analyzer or any other system. It is required to done before every  sample analysis. HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture. In the HPLC technique, a  liquid sample is passed over an absorbent material to test its efficacy. HPLC chromatography technique is used in pharmaceutical industries for research and testing purposes. Most of the pharmaceutical companies  follow a three-step approach to check the functioning of their High performance liquid chromatography systems- Initial System Qualification, Method  Validation and Suitability Testing (SST). System Suitability Test (SST) Selecting a proper System Suitability Testing mixture is essential to check the specifications of a liquid chromatographic system. System Suitability  Testing limits are accep...

Steps for HPLC Method Validation It is required to validate the HPLC methods used for analysis of pharmaceutical products. It is a regulatory requirement to verify all analytical methods. In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfactory and consistent results within the scope of the process. The analytical techniques refer to the way of performing the analysis. Validation is the procedure by which it is set up, by research facility considers, that the execution qualities of the strategy meet the prerequisites for the proposed application. All the investigative procedures that are planned for examining any specimen should be approved. The p...

Steps for HPLC Method Development Know about the different steps of the HPLC analytical method development in pharmaceutical analysis. Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating  parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be  simple, used column, mobile phase and buffer should be common. It can be done easily step by step. Following are the common HPLC method development steps. 1. Selection of HPLC Analytical Method 2. Selection of Chromatographic Conditions 3. Parameter Optimization 1. Selection of HPLC Analytical Method: First of all consult the literature that is available on the product. It will help you to understand the nature of  the product that will help to select the different parameters. A. Sample Preparation: Select method to prepare the sample according to its ...

SOP for Washing of HPLC Columns Standard operating procedure to wash the columns of High Performance liquid Chromatography used in analysis of Pharmaceutical products. 1.0 OBJECTIVE To describe the procedure for washing of HPLC column. 2.0 SCOPE This SOP is applicable for washing of HPLC column. 3.0 RESPONSIBILITY Officer/ Executive - Quality Control 4.0 ACCOUNTABILITY Manager - Quality Control. 5.0 PROCEDURE 5.1 For C18, C8, C6, Phenyl, CN, Amine column: 5.1.1 Change the mobile phase to filtered distilled water. 5.1.2 Allow the water to flow through the column at the rate of 1ml / min. For 30 minutes. Check that the pressure does not exceed 400 BAR. 5.1.3 Change the mobile phase from water to HPLC grade 80% Acetonitrile. 5.1.4 Set the instrument to flow rate 1 ml/ minute and wash the column for 30 minutes. 5.1.5 Ensure that the column contains 80% Acetonitrile. 5.1.6 Disconnect the column from the HPLC unit and store in an appropriate place. 5.2 For protein pack column: 5.2.1 Change t...

SOP for Washing of HPLC Column After Use Standard operating procedure to wash the HPLC column after analysis. 1.0 OBJECTIVE To clean the column thoroughly after its each use to avoid any interference on repeated usage. 2.0 SCOPE This procedure is applicable for different groups of H.P.L.C columns used in Quality Control laboratory. 3.0 RESPONSIBILITY 2.1 Doing: Technical Assistant 2.2 Checking: Executive /Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 For C18, C8, C6, Phenyl, (CN, Amine, Silica column.:) 5.1.1 Wash the column with the solvent which is use in individual product mobile phase preparation. eg. suppose water is use in mobile phase  preparation then wash the column with water. 5.1.2 Allow the minimum 30 ml washing medium to flow through the column. 5.1.3 Disconnect the column from the HPLC unit and store in an allocated place. 5.2 For Protein pack column: 5.2.1 Wash the column with minimum 30 ml of 2.5 M acetic acid. 5.2.4 Disconnect the column from ...

SOP for Verification of System Suitability Test Standard operating procedure to verify system suitability software results Vs manually of the high Performance liquid chromatography for result accuracy. 1.0 OBJECTIVE To Verify system suitability values manually v/s software. 2.0 SCOPE This procedure is applicable to verify system suitability software results Vs manually of the high-performance liquid chromatography. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant 3.2 Checking: Executive/ Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 Frequency: Once in 6 months. 5.2 Operate the instrument as per respective standard operating procedure of HPLC. 5.3 Prepare the mobile phase consisting of 70% methanol. : 30 % of water. 5.4 Prepare a mixture of 0.1 % Benzene and 0.1% Toluene in methanol. 5.5 Set flow rate at 1.0 ml/min. 5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample. 5.7 Record the area and retention tim...