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

OPENCLINICA AN OPEN SOURCE CLINICAL TRAIL SOFTWARE

OpenClinica is the world's first commercial open source clinical trial software for Electronic Data Capture (EDC) Clinical Data Management (CDM). In just a few years since its first release, OpenClinica become one of the world's most widely adopted clinical trial software technologies powering research in over 100 countries. During this time, a rich community of innovation has arisen around OpenClinica making it both a

SAS - SOFTWARE FOR PHARMACEUTICALS

Statistical analysis is playing an increasingly important role in all fields of human life. We are often faced with the problem of analyzing and interpreting a large mass of data. Like many industries, the pharmaceutical industry has a vocabulary and language all its own. The role of statistical programmers is to use their superior

PRODUCTION TECHNIQUES & SCALE-UP TECHNIQUES

INTRODUCTION:

1.       RESEARCH AND DEVELOPMENT PERSONNEL EXPAND A CONSIDERABLE AMOUNT OF EFFORT DEVELOPING DRUG DOSAGE FORMS WITH EXACTING SPECIFICATIONS (ADEQUATE PHYSICAL&CHEMICAL STABILITIES).

2.       SCALE UP TECHNIQUES MUST INCLUDE A CLOSE EXAMINATION OF THE FORMULA TO DETERMINE ITS ABILITY TO WITH STAND BATCH SCALE AND PROCESS MODIFICATION.

SOP FOR HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (JASCO)

1.       PURPOSE

        The purpose of this SOP is

1.       To defined the operating procedure.

2.       To define the precautions to be taken during handling.

STANDARD TEST PROCEDURES (STPs) & LABORATORY RECORDS

Laboratory records should include the complete data derived from tests necessary to assure compliance with established specifications and standards including examination and assays.

v  A description of the sample received for testing with identification of source (that is, location from where samples was obtained), quality, lot number and date sample was received for testing. Where samples are

POWDERS

Smt. Dr. Jayanti Vijaya Ratna

Dear Students, Today I want to introduce to you one dosage form which is called as “Powder”. Powders were very popular dosage forms, once upon a time; at a time when it was common practice for a pharmacist to “compound” a prescription and dispense it. Today compounding is not thee and “oral powders” are almost nonexistent. Only you see occasionally, when old people or children cannot swallow tablets or capsules; the tablets or capsules are made into powders, by the people who are administering these medicines to them. Powders can be swallowed more easily but their taste is also felt more by the tongue. Let us today look at what are powders what are their advantages and disadvantages and let us consider a few prescriptions for powders. I want to just explain to you that the principles which are valid in the preparation of powders at a compounding level are also equally valid in the “manufacture” of powders or which are ultimately becoming granules in the preparation of tablets.

Classification of Powders:

1.     Bulk Powders for internal use

2.     Bulk Powders for external use

3.     Divided (single dose) powders

Advantages of Powders:

1.     When it is not possible to dispense a drug as a solution or a suspension, because of its insolubility or because it is susceptible to microbial continuation if it is wetted, then it is a good idea to dispense it as a