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GMP-SOP Blog

Guideline for the Validation of Excel Spreadsheets

Guideline for the Validation of Excel Spreadsheets

1       Purpose The purpose of this document is to provide guidelines for a suitable approach for the qualification of Excel spreadsheets used in direct, or in-direct, GxP related activities at all GMP facilities. 2       Scope The procedure applies to the initial qualification and re-qualification of Excel spreadsheets, designed and used for making quality based decisions in GxP environments at the GMP facility. These areas include but are not limited...
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Guidelines for Regulatory Inspections at a GMP Site

Guidelines for Regulatory Inspections at a GMP Site

It is essential that management develop, document and implement procedure(s) for managing inspections by Regulatory Authorities in order to protect the legal rights of the business (and the Regulatory Authorities to perform repeated inspections) and at the same time, to maintain a professional relationship with the regulatory authority conducting the inspection. Senior Management at a site or function must be present during key parts of an inspection. Inspection notification, ongoing highlights of the inspection, and...
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GMP – Its Everybody’s Responsibility

GMP – Its Everybody’s Responsibility

The term Good Manufacturing Practice, or GMP, refers to a set of licensing requirements to which companies must adhere in order to obtain and retain a manufacturer license. In the USA, these GMPs are called current GMPs (cGMPs), and are legally enforceable regulations. Internationally, GMP rules are referred to as codes, rules or guidance to GMP. Most countries use medicinal regulations that refer to these codes. · Explain why your company has implemented GMP ·...
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API – Impurity Profile Generation

API – Impurity Profile Generation

I.INTRODUCTION This SOP addresses those impurities in drug substances classified as degradation products of the active ingredient, impurities present in the drug substance as part of the manufacturing/storage process or reaction of the drug substance with an immediate container/closure system. II.DEFINITIONS A.Foreign substances: Materials introduced by contamination or cross contamination and are not consequences of the preparation of the drug substance. B.Residual Solvents: Organic volatile chemicals that are used or produced in the manufacturing process....
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Cleaning Validation Steps for GMP Plant

Cleaning Validation Steps for GMP Plant

A pharmaceutical manufacturing plant compliant with Good manufacturing Practice must have cleaning validation program in place to establish documented evidence that the cleaning processes will consistently ensures that the products produced will meet expectations for purity, identity, safety and quality. The purpose of cleaning validation is to ensure that no significant amounts of active ingredients or excipients carry over into subsequent uses of the equipment. Cleaning procedures are established in order to eliminate or reduce...
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Calibration Master Plan

Calibration Master Plan

1.0PURPOSE 1.1The purpose of the Master Calibration Plan is to define the requirements necessary for establishing and implementing an effective Calibration Control Program. The aim of the Calibration Program is to ensure that all Measuring and Test Equipment (M&TE) included in the program are calibrated to within the manufacturer’s accuracy specifications or to the tolerances required by the application. Documented trace ability to either the National Institute of Standards and Technology (NIST) or other applicable...
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Aseptic Filling Room Personnel Monitoring

Aseptic Filling Room Personnel Monitoring

PURPOSE To monitor viable organisms on the gloves hands, forearms and uniforms of aseptic filling room personnel. SCOPE This procedure applies to the aseptic filling room personnel monitoring at the applicable plant. RESPONSIBILITY It is the responsibility of the Microbiology Department to conduct this SOP as written. FREQUENCY At the beginning and at the end of aseptic filling of every production run (lot), gloved hands of all employees engaged in filling shall be monitored. Uniforms...
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Area and Equipment Cleaning Approval

Area and Equipment Cleaning Approval

PURPOSE: To establish procedure for area/equipment cleaning approval. PROCEDURE: PROCESS OPERATOR 1. Upon the completion of processing a lot of material, assure all completed products, waste and rejects are properly tagged & removed from the room. 2. Place a "to be cleaned" tag on the door of the processing room. 3. Perform cleaning and record in equipment logbook. Reference sop# xxx major/minor cleaning. Note:Refer to procedure for cleaning requirements relating to lapses in time between...
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API Packaging and Labeling Guidelines

API Packaging and Labeling Guidelines

I.INTRODUCTION The final step in packaging and labeling an active pharmaceutical ingredient (API) can also be considered as the first step in the manufacture of a dosage form. Consequently this step is important and should be performed in a manner consistent with the dosage form GMP requirements. II.STANDARD REQUIREMENTS A. Areas used for packaging of active pharmaceutical ingredients (API) where the API will not undergo further purification steps, need to meet the standards of the...
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API Cleaning Validation Requirements

API Cleaning Validation Requirements

I.INTRODUCTION A cleaning validation program must be in place to establish documented evidence that the cleaning processes will perform consistently, ensuring that the Active Pharmaceutical Ingredients (APIs) produced will meet expectations for purity, identity, safety, and quality. Cleaning procedures are typically shown to be adequate and appropriate in two ways, verification and validation. While often used interchangeably, the two terms are not the same. Verification of Cleanliness: Following each cleanup, the equipment is typically sampled...
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