SOP FOR HPLC ANALYSIS AND DOCUMENTATION

1.0   Objective

To describe the procedure to be followed in HPLC analysis and documentation and to insure that good laboratory practices are followed in the HPLC analysis.

2.0   scope

This SOP is applicable for the procedure to be followed in HPLC analysis and documentation and to insure that Good laboratory practices are followed in the HPLC analysis.

WET GRANULATION PROCESS

Wet granulation forms by binding the powder together with an adhesive, instead of by compaction, bridges are developed between the particles and the tensile strength of bonds increases as amount of liquid added is increased.

Wet granulation involved the massing of a mix of dry primary powder particles using a granulating fluid. The fluid contains a solvent which can be removed by drying, and should be non-toxic. Typical solvents include

PHARMACEUTICAL EXCIPIENTS

Ø  Excipients are those substances which are added to the formulation other than pharmacological active drug

Ø  Excipients have slight or no action and added to formulation to get the desire properties.

Ø  According to IPEC “Excipients are those product having slight or no action and intended to added in formulation to make formulation more effective.

TYPES OF PROCESS VALIDATION

1. Types of process validation

Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation (repeated validation).

Prospective validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps: these are then evaluated on the basis of past experience to determine whether they might lead to critical situations.

DIFFERENCE BETWEEN OUT OF SPECIFICATION (OOS) AND OUT OF TREND (OOT)

1.       OOS (out of specification) is the comparison of one result versus a predetermined specification criterion while OOT (Out of trend) is the comparison of many historical data values versus time.

CLEANING VALIDATION PROTOCOL FOR PHARMACEUTICALS

1.      Introduction:

The validation of the cleaning procedures is establishing documented evidence that the procedure is effective and capable for removing the contaminants associated with previous products, residues agents as well as the control of potential microbial contaminants.

The cleaning validation is not only ensure the compliance of the regulatory requirements, but a more important benefit for performing cleaning procedure validation is the identification and the correction of the potential problems which could compromise the safety, efficacy or quality of the subsequent batches of drug product.

DRUGS PRICE CONTROL ORDER

INTRODUCTION: Drugs are recognized as ‘essential commodity’ Should always be available to the general public at a reasonable price In absence of any statutory control a manufacturer could sell a drug at exorbitant price which is not only against public interest but also against the concept of welfare state

The drug price control order has been promulgated : 

To fix the maximum retail prices of drug formulations To curb the exorbitant profiteering in drug manufacturing and