Quality Control System:-
All personnel engaged in QC are experienced, competent and technically qualified to perform activities of the department. QC is responsible for sampling & analysis as per approved specifications. Authority to approve/reject the material lies with QC but the final release of all materials performed by QA Laboratory is well equipped with all modern instruments and has facilities for chemical, instrumental testing. There is a separate room for retaining control & stability sample. Temperature & humidity record is maintained for all rooms.
Primary standards, secondary standards, reference standards, working standards are maintained. All relevant protocols, logs are maintained for preparation & handling of secondary standards & working standards. Volumetric solutions are prepared & standardized at defined frequency & records are maintained. For all such activities, SOP’s are available & training are also conducted.
Documents are maintained as per SOP. Electronic data is maintained by taking regular back up.
Calibration, AMC, Preventive Maintenance:-
All instruments used for the analytical purpose are operated & calibrated as per respective SOP’s. Calibration programme is planned which includes an instrument to be calibrated, frequency of calibration. On replacement/repairing of any part of instrument partial or complete calibration is performed & recorded. Standards used for calibration are assured for traceability & its validity. All instruments have a calibration status label which indicates calibration date & next calibration date, instrument name & signature of person calibrating the instrument. History card is also maintained for each instrument. It will help to identify precaution to be taken if the same problem arises and / or which parts should require frequently; so that stock can be maintained to avoid discontinuation of work. Almost all instruments are under AMC with the vendor. AMC reports are also maintained by the department.
Preventive maintenance schedule and SOP is followed for all instruments. Reports of same are also maintained.
Stability studies are carried out as per the IPEC Excipient stability program guide 2010. Only long term stability is applicable to products manufactured under FDA license.
Conditions are as follows:-
Long Term Stability Study-
Temperature: 25°C ± 2°C ; Relative Humidity: 60% RH ± 5% RH
Stability protocol, stability schedule, stability reports, stability data format & stability label available to support the system. Stability samples are stored in a secured area. A temperature & humidity record of stability sample storage room is maintained.
QC has an important role in Validation. It includes process, cleaning & method validation. While performing process & cleaning validation QC has to confirm & assure that sample is passed as per predetermine criteria & record has to be maintained. While performing method validation various parameters should be considered before actual implementation by referring USP, ICH etc. whichever is applicable & suitable. All these records are maintained by the department. Such method validation reports are also intimated to the customer prior to implementation either verbally or by mail.
QC kept control sample for each batch of every Finished good. All details are recorded in control sample register such as product name, product grade, manufacturing date, expiry date, quantity kept, sample kept by, disposal date etc. 1-litre quantity is kept for the control sample. Control samples are stored in a secured area. A temperature & humidity record of control sample storage room is maintained. Control samples are retained for 6 months after the expiry of the product. In case any complaint received, the control sample is used to confirm the problem & record of usage is maintained.