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Friday, August 14, 2009

Quality Assurance Systems Pharmaceuticals manufacturing

Pharma Quality Assurance Systems
Quality assurance for pharmaceuticals is very important aspect in manufacturing of pharmaceuticals.

There is following simple points for quality assurance aspects in pharmaceutical manufacturing
1. In process quality assurance
2. Finished product quality assurance.
3. Assuring Quality of ingredients used to make pharmaceuticals

Quality assurance is a systematic approach and process where a pharmaceutical which is manufactured is being certified as safe and complying with all standards and regulations and requirements of FDA.

It is not just because FDA requires the pharmaceutical manufactured is of good quality, but it is moral responsibility of each personnel associated with pharmaceutical manufacturing in the manufacturing company.

The system of quality assurance should be designed to to produce a very good quality pharmaceuticals, the systems developed should be able to prevent all sorts of noncompliance, they should merely not point after a noncompliance has occurred but they should effectively systematized to function as a chain reactions , where in if some failure occurs at any given point the chain should break and alert the concerned person responsible individual.


1.Raw material dispensing
1.During dispensing activity of active pharmaceutical raw material , one should checke
1. Assay of active ingredient
2.Assay calculation , and reports of Material
3.Physical appearance of material
4.Calibration of balances
5.Temperature records
6.Laminar air flow bench cleaning , filter cleaning and pressure and air flow.
7.Condition of Material
8.Tare and net weight while dispensing of material
9.Manufacturing and expiry date of material
10.Cleaning of utensils and scopes used
11.Personal hygiene
12.Status labels over material containers
13.Storage of material.
14.Documentation of all dispensing activity
15. Quarantining dispensed material for day’s storage aria in proper lock and key arrangement.
And so on

If listed in proper format, and handed over to the Quality assurance personnel who do dispensing activity , and train them to check these points while dispensing of material , One will be able to point out and rectify almost every critical noncompliance’s which would prove fatal .

Good quality pharmaceutical manufacturing starts with building of quality assurance systems , and raw material quality is the most important aspect of quality of pharmaceutical manufactured by you , above system takes care of all raw material quality issues before is added in to the actual batch of pharmaceutical , you check again
assay , and its calculations , and all relevant things about material .

While start up of new batch, stringent verification of all cleaning activity, presence of previous products, and labels, packaging material or traces, by doing rinse analysis, and documentation, assures prevention of cross contamination

Most of times many noncompliance's are identified and compiled at the point of Dispensing of raw material it self .

2. Addition of active ingredient

Addition of active ingredient in presence of quality assurance personnel.
This activity too is very important in manufacturing of pharmaceuticals.
Quality assurance personnel checks dispensing activity of raw material, assay report and calculations, etc.

QA person checks addition of raw material in his presence, and certifies that the material is properly added in the batch along with production personnel and documents.

3.Water is the very important ingredient in pharmaceuticals , hence its microbial quality and report should be verified every day by QA , we suggest to carry out test for acidity and acidity and alkalinity as this test is very peculiar , even the PH and conductivity are complying some times you may find that test for acidity and alkalinity giving results which are not complying , this is rare in today’s highly efficient water systems available but , incorporate this in your day today quality assurance monitoring .

4. Volume make up and weight of bulk

This aspect too is very important.

Verification of volume make ups and final weight of a batch by quality assurance personnel is very important activity these activities takes care of all sorts of errors due to volume and weight make up.

5. In process fill weight and fill volume checks.


So far we discussed about 1 , Dispensing of raw material , Addition of active material in to batch 3.Volume make ups and weight variation of bulk products

At all steps Quality Assurance QA is on the lead front .

Final process of filling in case of liquid dosage form and weight, and weight variation checking in case of compression of tablets, ensures that the dosage form is properly compressed, formed, and filled; the active material too was checked and found of good quality before addition to batch.
The water used too is verified.

6.Releasing of BatchSystem to release a batch of pharmaceutical to market should include verification of

Finished product analysis report.
Microbial load test results , and assays of active ingredients ,
Batch manufacturing record
Sterility test reports in case of injectables
Review of records of all steps from bulk manufacturing to packing .
Yield analysis
Pack line check list for verification packing activity.
7.Online packing line check list:
This is a very important system , in most of the pharmaceutical companies we have seen this system.
This consist of online packing activity checking format , which requires that a quality assurance person to check all the points of packaging activity and document them in a proper way while the packing activity is going on , just as described for manufacturing stage , a good format developed to cover all activities in packing line , provides a assurance of quality for pharmaceuticals manufactured in your company. we have a sample document format loaded over this website find it here.

8.Stability testing

9. Annual Product Quality Review: 
Annual product quality review is one of important tool of quality management system systematic review of product quality provides complete guidelines for managing quality of pharma product.

10.Challenge QA system to validate its complete effectiveness :We recommend you to adapt a challenge validations at each and every point in your quality assurance systems.

11.Pharmaceutical Process Validation , it is very important that the process which are being used to produce drug product are duly validated updated further , as it is one of the mandatory requirement of current good manufacturing practices gmp guidelines. Also see Pharma process validation

What is meant by challenging a effectiveness of validity of a working system: 
One should challenge a quality assurance systems we described in brief , to make sure that these are working properly , the system , the trained peoples , the environment responds in positive manner to a challenge placed in to the system to identify any type of discrepancy while manufacturing or process ,
The defect , or discrepancy is identified and rectified in proper way for which a quality assurance system is made for.
For example

We have seen peoples who can identify a defective ampule of a injection in the process of visual inspection once it is knowingly placed with a peculiar marking in to the complete batch , a trained person is able to remove the defective ampule very effectively , likewise a QA in process QA personnel is also able to find any discrepancy , if the format of inspection is properly made and asked to fill by doing proper exercise .

We have provided all sorts of formats and guidance for above 7th and 8th points and other Quality assurance aspects in pharmaceuticals over this website.

The Quality Assurance Department should design and operate quality assurance system in such a way that they derive the quality of manufactured product by the designing of there quality assurance systems, the system in place generate best quality pharmaceuticals

Similarly Pharma Quality Assurance System designed for, cleaning, personnel hygiene, personnel training, line clearance, validations are equally important which are discussed in depth with sample documents over this blog in earlier posts.

We have provided over this blog questions and answers for personnel training.

Standard operating procedures SOP for microbiology and aseptic techniques for manufacturing of sterile dosage forms injections , pharmaceuticals , pharmaceutical validations

This Website is a Guide for Pharmaceutical Manufacturing Pharmacy Students Pharmacy Colleges and Pharmacists pharmaceutical companies health care professionals
Regulatory affairs in pharmaceutical industry

Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Clean Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry

1 comment:

Hapi said...

hello... hapi blogging... have a nice day! just visiting here....

Posted by: Martin

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