Hold Time Study Protocol of Sterilized Garments for their Sterility

1.0  OBJECTIVE
Objective of this protocol is to provide documented evidence to establish and verify the microbial presence on sterilized garments upon holding up to 5 days after sterilization by using the microbial detection method.
2.0  SCOPE
The scope of this protocol is to evaluate the hold time after sterilization of garments. This shall be done by using established microbiological method to determine the microbiological growth.
3.0  REFERENCE DOCUMENTS
Following documents are referred during preparation of the protocol
3.1  SOP for Sterility Testing
3.2  SOP for Garment Cabinet

Validation Protocol for Hold Time Study of Collected Water Samples

1.0  OBJECTIVE

Objective of this protocol is to provide documented evidence through the scientific data to establish and verify that on holding water for over a period of 72 hours after collection and subsequent storage does not affect its results for different parameters such as Description, pH, Conductivity, Heavy metals, Nitrates, TOC, Total count and BET.
2.0  SCOPE

The scope of this protocol is to evaluate the hold time of water samples upon holding for 72 hours.
3.0  REFERENCE DOCUMENT

Following documents are referred during preparation of the protocol.

Water sampling procedure

Procedure for analysis of Water

Validation Protocol for Hold Time Study of Sterilized Glassware and Accessories

1.0  OBJECTIVE
       Objective of this protocol is to provide documented evidence through the scientific data to establish and verify the microbial presence on sterilized glassware and accessories upon holding up to specified time after sterilization by using the microbial detection method.
2.0  SCOPE

       The scope of this protocol is to evaluate the hold time of sterilized glassware and accessories after sterilization.

Validation Protocol for Hold Time Study of Prepared Inoculum Suspension

1.0  Objective

Objective of this protocol is to provide documented evidence through the scientific data to establish and verify the stability of prepared microbial suspension upon holding for a period of time.

2.0  Scope

The scope of this protocol is to evaluate the hold time of prepared inoculum suspension (CFU/ml) upon holding up to 15 days. This protocol shall also define the storage conditions effectiveness of inoculum stored at 2-8° C.

Validation Protocol for Efficacy of Disinfectants

1.0  Objective

This document describes the testing procedure for the Efficacy of Disinfectants.

2.0  Scope

This document provides the procedure for validating the sanitizers and the sanitization procedure being followed in the manufacturing and the testing facilities in pharmaceuticals.

3.0  Reference Document

SOP for microbiological culture media preparation

Disinfectant Efficacy Test

Validation Protocol to Determine the Shelf Life of Prepared Microbiological Media

1.0  INTRODUCTION

The most important thing is to ensure that various media used during any test, support microbial growth to consider the test results as valid. The ability of the nutritive media to support the microbial growth is mainly influenced by pH, physical description and water content. Thus it is essential to check that, at the time of usage these parameters are unaffected, which can be done by checking the pH and carrying out growth promotion test.

Solid Pharmaceutical Dosage Forms - Capsules

Capsules are solid pharmaceutical dosage forms in which the drug or a mixture of drugs is enclosed in a Gelatin Shell or any other suitable material to form various shapes. Capsules generally contain a single dose of active ingredients and are taken orally. Excipients such as opaque fillers, antimicrobial preservatives, sweetening agents, permitted flavoring agents and one or more coloring agents may be added. Capsules may be printed on outer surface.

Self Inspection and Quality Audits

1.  Introduction:
Self inspection is basically a method of objective overall review of one’s own operation on aspects that may have on quality effect on quality assurance. In general, self inspection aims at identifying defects whether of critical, major or minor nature. Self inspection should be conducted by designated competent persons from the company. Self inspection program is conducted in order to monitor the implementation and compliance with current GMP principles and to ensure that the necessary corrective measures are taken.

Sterile Pharmaceutical Dosage Forms - Parenteral Preparations

Introduction

Parenteral preparations are sterile products those are administrated by injection into the body. They may be directly administrated or they may be diluted before administration.

Production of Parenteral Products

Parenteral preparations are prepared by the methods that maintain their sterility, avoid the introduction contaminants and microbial growth.

Oral Liquid Pharmaceutical Dosage Forms

Oral liquids are homogeneous liquid preparations, usually contains a solution, an emulsion or a suspension of one or more active ingredients in a suitable liquid base. They are prepared for oral administration either as such or after dilution. They may contain other substances such as suitable dispersing, solubilizing, wetting, emulsifying, stabilizing, suspending, thickening agents and antimicrobial substances for preservation. They may also contain suitable sweetening agents, flavoring agents and permitted coloring agents. If sodium saccharin or potassium saccharin is used for sweetening, then its concentration in pediatric preparations should not be more than 5 mg per kg of body weight.

Preparation of Annual Product Review

1.0  The majority of GMP regulatory bodies has made it a mandatory for the companies to have a written procedure for the Annual Product Review process, and recommends review of all the batches that are manufactured in the preceding year from January 1^st to December 31^st. And the batches include both approved as well as rejected batches.

2.0  The configuration of an annual product review report can vary based on different products and a company’s specific documentation requirements.

Performance Qualification of Isolator Systems

1.0  PROCEDURE
1.1  Validation Test Procedure: The HVAC system will be considered qualified for consistent and reliable performance (Validated) on successful completion of the following tests.
1.1.1  Air velocity measurement studies
1.1.2  Integrity testing of HEPA filters
1.1.3  Differential pressure monitoring
1.1.4  Non viable particulate monitoring
1.1.5  Power failure recovery study
1.1.6  Air flow direction
1.1.7  Microbial monitoring
1.1.8  Lighting and sound level monitoring
1.1.9  Temperature and RH monitoring
1.1.10  Bio-decontamination study
1.1.11  Chamber leak test

Solid Pharmaceutical Dosage Forms - Tablets

Introduction

Tablets are solid dosage forms each containing a unit dose of one or more active ingredients. They are intended for oral administration. Some tablets are swallowed whole or after being chewed, some are dissolved or dispersed in water before administration and some are retained in the mouth where the active ingredient is liberated.
Because of their composition, method of manufacture or use, tablets are of a variety of characteristics and  there are several categories of tablets. Tablets may be coated or without coating.