|
|
| |
|
|
|
| |
|
|
| |
|
|
|
|
|
| |
Quality Control |
|
| |
 |
|
| |
Our New Products |
|
| |
 |
|
| |
Our Contacts |
|
|
|
|
| |
Office :- |
|
| |
328-329, Paradise Complex
Sayajigunj,
Baroda 390 005,
India
91-265-2362319 / 2362966, 6641924, 6457170
91 - 265 - 2226 093 |
|
| |
|
|
| |
| |
Reg. Office :- |
|
| |
161
Kika Street
Gulabvadi Mumbai-400004
Maharashtra
| |
| |
|
|
| |
Factory :- |
|
| |
Plot No.165/P
At. Vadadala
Tal. Savli, Dist Baroda 391520
India
91 - 2667 - 2510522 |
|
| |
|
|
|
|
|
|
|
|
| QUALITY CONTROL |
| We at REKVINA have a strict and effective Quality Control System. Quality is the primary aspect for our success. Quality if comes secondary on the agenda of a company would certainly mean disaster, not only for a company but also for human lives especially when it is a Pharma company. at Rekvina we are committed for providing excellent quality drugs, as it only the Quality which comes first on our agenda. The quality control at Rekvina can be understood as: |
| |
QUALITY CONTROL SYSTEM :
We have recruited the best and highly technical and qualified experts to look after the Quality Control Department. This department keeps a thorough check on the quality of every batch we manufacture. |
The process for Quality Control at Rekvina can be described in a simple manner as follows:
- Release/rejection of each batch of raw materials and excipients.
- Testing of intermediates.
- In process checking at all stages.
- Test stability of products keeping in mind all the environment variations that the drugs could be exposed to.
- To maintain operating procedures of products and process specifications with consent of production/I.P.Q.C (Q.A)/B.P/U.S.P/ and as per the instructions of General Manager.
|
STANDARD OPERATING PROCEDURES DURING MANUFACTURING:
There are some standard operating procedures that are to be followed before starting a batch. It includes cleaning and sanitation, setting up of machine, precautions to be taken before starting production, checks to be done before and during manufacturing process. These procedures are validated periodically as and when changes are necessary.
STANDARD OPERATIONS PROCEDURE FOR VALIDATION:
All the batches manufactured, should be complied with the conditions specified in the current Master Formula Card. Deviations, if any, must be mentioned where ever necessary.
Analysis of the product/process is as under .
Tablets Capsules
- Weight Variation: - Filled weight of the capsules
- Disintegration: - Disintegration time
- Assay: - Assay
- Dissolution: - Dissolution time
- Other related tests of the product: - Other related tests of the product
Each batch shall comply with the criteria specified by IP/BP/USP for product validation
The test results are tabulated. If they fall within specifications they are accepted, otherwise through analysis of the conditions/process in that particular batches would be analyzed, and related changes would be made. After this the process is revalidated. |
|
|
|
|
