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.

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

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.

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.