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.

The in process tests are performed by production or quality control personnel. These are important for process validation purposes.

These in process tests provides early warnings of conditions that could lead to an out of control situation & allow corrective action before that condition occurs.

These tests fix acceptance level for materials.

In process checking during manufacturing plays an important role in the auditing of the quality of the product at various stages of production. The objective of this in process quality systems is to monitor all features of a product that may affect its quality & prevent errors during processing. Common methods followed for different dosage forms are as follows.

Parenteral Products:

ü  Checking the bulk solution before filling for drug content, pH, color, clarity of solution.

ü  Checking the filled volume.

ü  Testing for leakage of sealed ampoules.

ü  Subjecting the product to physical examination for appearance, clarity, particulate contamination.

ü  Submitting the product for sterling testing.

Solid dosage forms:

ü  Determining drug content of formulation.

ü  Checking the weight variation for tablets & capsules at predetermined intervals.

ü  Checking the disintegration, dissolution time, hardness, friability of the tablets at different time intervals.

ü  Inspecting the finished products for defectives.

Semisolid preparations:

ü  Checking for uniformity homogeneity of drug content.

ü  Determining the particle size of preparation.

ü  Checking the appearance, viscosity, specific gravity, physical parameters at prescribed intervals.

ü  Testing for leakage on the finished jars or tubes.

At the manufacturing bulk finished products are held in quarantine until they are released for packaging by quality control personnel.

In process quality control program includes testing and inspection functions for monitoring the environmental conditions under which products are manufactured.

ü  Control of packaging components

ü  Documentation

ü  Raw materials

ü  Manufacturing equipment

ü  Sampling procedure

Environmental control & sanitation:

Different levels of control are established depending on intended use of dosage form.

Parenteral & ophthalmic products are manufactured in controlled environment to protect their sterility.

Monitoring of air & water systems are critical in ensuring that they are being controlled & levels of particulates & microbial matter are within established limits.

In the parenteral & ophthalmic products manufacturing area class 100 (an area that can be controlled to contain fewer than 100 particles of size 0.5 µm less per cubic foot of air) is maintained.

In the manufacture of non-sterile products, acceptable level of particulate & Microbial matter is defined & then environment Is controlled to the defined level.

During testing, steps must be taken to firing the levels within acceptable limits to manufacture the quality product.

Adequate temp, proper humidity, adequate ventilation should be present.

Ventilation is required to remove dust during granulation, coating & compression departments. In these departments air filters dust collectors are checked on a routine schedule.

Water supply should be potable, distilled, or deionized to keep the water flowing clean. Deionization units are checked to deliver quality water as per specification.

Documentation:

All the component materials, processing steps, production operation specification & equipment used are documented. This forms linkage between written records of action taken & the quality operation.

This helps in control of product during distribution.

Raw Materials:

These raw materials are weighed in an environmental control weighing area where they are transferred to a secondary container that circulates into production department.

This secondary container should be properly labeled. Only raw materials with proper reassay dates are allowed in production department.

If raw material is to be taken in its original container into production area, then it should be checked for cleanliness.

Raw material intended for use in specific products should be isolated together with proper identification, name dosage form lot number, weight & signatures.

Manufacturing equipment:

These should be designed placed, and maintained in such a way to facilitate through cleaning.

Equipment should be thoroughly cleaned according to the specifications.

Proper equipment & tooling must be used for each manufacturing step.

Equipment must be labeled.

Weighing & measuring equipment should be calibrated.

Records of tests should be maintained.

Control of packing components:

These materials must be inspected & tested against rigid specifications to ensures that they meet, functional standards.

Container specification:

ü  Properties of container tightness.

ü  Compatibility between container & product.

ü  Physical or chemical changes of container upon prolonged contact with product.

ü  Toxicity & physical & chemical characteristics of materials needed in container construction.

Finished Products:

These Products are tested to determine compliance with specifications.

This testing assures that each unit contains the amount of drug claimed on label, & that all of drug in each unit is available for complete absorption drug is stable in formulation in its specific final container closure system.