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

INPROCESS QUALITY CONTROL

This Program ensures finished dosage forms have uniform quality and purity within a batch and between batches.

This program is accomplished by identifying critical steps in the manufacturing process and controlling them within defined limits.

SUPER INFECTION

Super infection, according to Dorland’s illustrated is a condition produced by sudden growth of a type of bacteria, different from the original offenders in a wound or lesion under treatment.

In virology, super infection is the process by which a cell that has previously been infected by one virus gets confected with another virus at a later point in time. In medicine, super infection is an infection, especially

DRUG RESISTANCE

Drug resistance is the reduction in effective of a drug in curing a disease or improving a patient’s symptoms when the drug is not intended to kill or inhibit a pathogen then the term is equivalent to dosage failure or drug tolerance. More commonly the term is used in the context of diseases caused by pathogens.

Pathogens are said to be drug resistant when drug meant to neutralize then have reduced effect.

CHEMOTHERAPEUTIC INDEX

Chemotherapeutic agents need to act at a concentration that can be tolerated by the tissues of the host and therefore they must have a selective toxicity for micro organism compared with the host.

This selective toxicity expressed in terms of the “Chemotherapeutic Index” that compress the maximum dose that can be tolerated by the host without causing death (The maximum tolerated dose) with the minimum

NON PHARMACOLOGICAL THERAPY OF HYPERTENSION

Weight reduction and regular aerobic exercise (E.g: Jogging) are recommended as the first step in treating mild to moderate hypertension.

Regular mild exercise improves blood flow and helps to reduce resting heart rate and blood pressure.

These steps are highly effective in reducing B.P.

EYE DROPS

Definition: Aqueous or oily solutions or suspensions for instilling into the conjuctival sac.

Eye drops are used as

ü  Anaesthetics,

ü  Anti-inflammatory agents

EXHIBIT BATCH VS PILOT BATCH

Exhibit batch is one which can be manufactured in production plant or even in pilot plant which have similar equipments such as in production facility. An exhibit batch is also called LATE PILOT BATCH which is used to provide the major stability data as per ICH guidelines to submit for an ANDA application.

PREVENTION OF CROSS-CONTAMINATION DURING PROCESSING

       Line clearance should be performed as per SOP & check list and recorded.

·         Check for absence of any starting materials, products, product residues, documents of previous product.

·         Wherever possible adopt “Closed system” while handling materials.

·         Processing of only one material at a time in same cubicle.

SOP FOR BURSTING STRENGTH TESTER

Objective

To provide a procedure for the operation of bursting strength tester.

Scope

Applicable to the bursting strength tester in quality control department.

PRINCIPLE AND CALIBRATION OF ULTRAVIOLET AND VISIBLE ABSORPTION SPECTROPHOTOMETRY

Ultraviolet and visible absorption spectrophotometry is the measurement of the absorption of monochromatic radiation by solution of chemical substances, in the range of 185 nm to 380 nm, and 380 nm to 780 nm of the spectrum, respectively.

The magnitude of the absorption of a solution is expressed in terms of the absorbance, A, defined as the

CALIBRATION OF UV/ VISIBLE SPECTROPHOTMETER

Ensure that the connection of the instrument are proper.

Control of absorbance

Potassium dichromate solution:

Dry a quantity of potassium dichromate by heating to constant weight at 130°C. Weigh & transfer accurately

CALIBRATION OF FT-IR SPECTROPHOTOMETER

Check that all the connections of the instrument are proper.

Ensure that printer is attached to the instrument.

Attach sample compartment.

Log in the software.

CALIBRATION OF DISINTEGRATION TEST APPARATUS

     A)     Number of cycles (With a constant frequency of 29 to 32) per minute:

1.       Record the frequency of moving up and down of the basket rack assembly, in a given time as shown below.

Start Time (Mins.)	End Time (Mins.)	Side A (Left hand side of the operator).		Side B (Right hand side of the operator).
		No. Of cycles (A)	No. Of cycles per min. (A/5)	No. Of cycles (B)	No. Of cycles per min. (B/5)
0	5
15	20
30	35
45	50
60	65

CALIBRATION OF BROOKFIELD VISCOMETER

Procedure:

Ensure that all the connection of the instrument is proper.

Turn the viscometer ON.

Take out the viscosity standard solution in 500ml beaker, adjust the temperature to 25° C. Attach the

ATOMIC EMISSION SPECTROMETRY

The technique is used to determine the concentration of certain metallic ions by measuring the intensity of emission of light at a particular wavelength by the vapour of the element generated from the substance. The measurement of the intensity of one of the emission lines of the atomic vapour of the element generated from a solution of that element is the basis of atomic emission spectrometry. The determination is carried out at the

ATOMIC ABSORPTION SPECTROMETRY

This technique is based on the fact that when atoms, ions or ion complexes of an element in the ground state are atomized in a flame, they absorb light at the characteristic wavelength of that element. If the absorption process takes place in the flame under reproducible conditions, the absorption is proportional to the number of absorbing atoms.

ASSAY OF CALCIUM CITRATE

Reagent required

3n Hydrochloric acid

0.05M Disodium Edetate

Sodium hydroxide solution

ASSAY OF CALCIUM CARBONATE

Reagent required:

Dilute hydrochloric acid

0.05M Disodium Edetate

Sodium hydroxide solution

ASSAY OF ASCORBIC ACID

Reagents Required:

1.0M Sulfuric acid

0.05M Iodine

Procedure

ANALYTICAL BALANCE CALIBRATION

CALIBRATION OF TOP PAN BALANCE

Calibration procedure:

Internal Calibration

It shall be performed as per the manufacturer’s instructions.

Drift Check

SOP FOR CALIBRATION OF HOT AIR OVEN

1.0  OBJECTIVE

To describe the procedure for the calibration of hot air oven

2.0  SCOPE

This SOP is applicable for the calibration of hot air oven.

APPEARANCE OF SOLUTION

Clarity of solution

Standard Suspension

Dissolve 1.0 g of hydrazine sulphate in sufficient water to produce 100.0 ml and set aside for about 6 hour solution add 25.0 ml of a 10.0 per cent w/v solution of hexamine, mix well and allow to stand for 24 hours.

ANALYTICAL METHOD VALIDATION

  1.       Principle

1.1   This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed and may be acceptable. Manufacturers should choose the validation protocol and