The company is engaged in the business of formulation in a dosage form. The major profile of quality control includes bio-availability of drugs (in-vitro), microbiological loading on dosage form and presence of volatile matters in the coated. Besides this the quality control carries out accelerated time study on new formulations and real time study to validate the manufactured formula and expiry date. The microbiological department of the company carries out the bacterial count of area by taking air samples thus validating the cleanliness procedure and suitability of particular of particular area as per requirement. The quality control also analysis the dosage delivery system. In case of sustain release tablets the solubility profile is analyzed as per time schedule.

1. Input Testing: In the manufacturing of formulation the supplier of bulk drugs and their production batches keep on the changing, so it is important to maintain the standard of raw material used for manufacturing. For this purpose IR graphs of the bulk drugs as reference standards and physical drug in liquid or solid form are kept as working standards. At present the company is having reference/working standards for more than 500 bulk drugs. The bulk drugs are tested for its purity as per pharmacopoeia and in house standards. The company is also testing impurities in these bulk drugs. Various pharmacopoeias like British Pharmacopoeia, United States Pharmacopoeia and European Pharmacopoeia are consulted to test the impurities. The standards operating procedure for analysis is made by the company. These standard operating procedures are revalidated from time to time. It means as and when new testing methods are published in pharmacopoeias with the use of HPLC and FTIR, old methods are replaced with more accurate methods of HPLC and FTIR.

2. In-process Testing: Following the GMP and ISO norms all in process control and testing is done and the Standard Operating Producers (SOP's) are followed. After each and every operation of manufacturing in every section, the in process testing is done by the manufacturing department and where required by the quality control department as per SOP. For example, in the tablet section weight of the tablet is adjusted by the manufacturing department, and the bulk granules, where required are tested for contents per gram by quality control department. The weight variation is controlled in the process. Similarly the other operations for different sections of manufacturing follow the pursuit.

3. Finished Product Testing: Before the sale of goods, the finished product is subject to final report of quality control department. This report is called as analytical report. If the final product is pharmacoepial, the finished product is strictly tested for all the standards laid down in a particular monogram of pharmacopoeia and for non-pharmacoepial products, in house testing procedure is followed.

MAIN INSTRUMENTS

FTIR
Shimandzu make FTIR-8301 equipment is installed in instrument room of the laboratory. The additional equipment required as an attachment is a computer, coloured printer and KBR press. The press makes a tablet of KBR/KCL of the material to be tested. The qty. 300 mg. of KBR/KCL is taken in a mortar & pestle where 3 mg. approx. of the material to be tested is added, both are grinded and mixed together. The mixed material is used in making tablet with the help of KBR press. This tablet is installed in the path of infra red rays. The graph is obtained on the computer screen with the use of software made for this purpose. However, the liquids can also be tested without the help of KBR with special arrangement provided with the instrument. The equipment is operated through computer. This equipment studies the comparative results with reference standards graph or with references/working standards.
HPLC

This equipment is operates with computer and a specialised software for this purpose. Normally c-18 column is used in this equipment. However the company is also having number of other columns. This equipment gives comparative study results with reference/working standard. It also confirms certain identification test.

Titrometer
This is logic control programmable Orion make titrometer for accurate calculation and results of non-aqueous titration, potienciometric titrations and aqueous titration. It is attached with a printer to take recorded result which is helpful for quality control reliable records.

Spectrophotometer
The company have double beam UV Spectrophotometer attached with computer & its software. Most of the material can be tested qualitatively and quantitatively by making solution of a particular strength in acid or alkali, aqueous or alcohol. Sometime the colour development is done by adding die or indicator.

Dissolution Test Apparatus
The analysis of solubility profile for tablet / capsules is done by this instrument. It is also used for extend release tablets / capsules. This apparatus is having six bowls in which acidic or alkaline buffers are filled. The tablets are put in these bowls, after a particular time a sample is drawn and the availability of bulk drug is tested in these samples. The unit incorporate a microprocessor base circuit for pre-programming and to carry out simultaneously six samples of Tablets / Capsules as per IP / BP / USP Standards. It is equipped with screen displaying temperature stirrer RPM, elapsed time, set alarm interval, real time and date which can be printed with attached printer to maintain the record. The solubility profile is also used as an in-vitro bio availability of formulation in tablet / capsules.

Other facilities
This includes equipments like pH meter, melting point apparatus, Karl Fisher apparatus, Flourimeter, Conductivity meter, B.O.D incubators, leak test apparatus, polarimeter, Microscopes, incubators, Loss on drying apparatus, Muffle furnace, Ultrasonic bath, glass apparatus, weighting balances, viscometer, hardness tester and friability test apparatus.

Bacterial Endotoxin
Since implementation of this test in June 2002, the Company has started testing its injections for bacterial endotoxinin in-house facility. The pyrogen tests are also performed on bulk and injections.

 
 
 
 
 
 
 
 
 
 

 

   
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