General Descriptions of Quality Control Department is a concept which stocks to produce a perfect product by series of measure design to prevent and eliminate errors at different stages of products. It is the most essential component of the drug industry and quality control may be easy for a well equipped and qualified staff i.e. as the necessary facilities including analytical instruments like HPLC, UV, K.F, and other necessary instruments as well as required chemicals. Q.C is essentially concerned with routine examination of a limited range of raw material intermediate and finished products. The laboratory is usually required to carryout the following type of testing, chemical analysis, instrumental analysis, general microbiological testing and routine testing. The division of the laboratory into sections is made according to the techniques used for the different product analysis.
GENERAL RULES FOR Quality Control Department
- Quality Control department is an independent department. Unauthorized persons are not allowed to enter this department. Only limited excess to this department is allowed for authorized persons.
- Laboratory it self consist of eleven rooms connected with each other.
- During working in quality control laboratory a number of measures are taken to secure the safety of the staff.
- White cotton lab coat must be wear during working inside the department.
- Glasses to be wear as per requirement for safety purposes.
- Gloves are used to protect hands from chemicals and heat.
- Masks must be used during working of dangerous materials.
- First aid box is placed in quality control department containing necessary medicines for the use of quality control staff.
- Quality Control Department is air conditioned by separate split air conditioning units to maintain temperature between 15-300C.
- Approximately 05 – 08 persons are working in the quality control department.
Structure of Quality Control Department
The Quality Control lab is situated on 1st Floor. The structure of which is given below:
These rooms are labeled as per map drawn bellow:
Micro instrument room
(Control Sterile area)Microbiological Test Room
Buffer Area 1
Quality Control manager Room Main Entrance
Keeping sample Room
General & Chemical lab
Quality Control Department is divided into following rooms:
- Quality Control Manager Room
- Main Laboratory
- Microbiology Lab
- Buffer Area
- Record Room
- Instrument Room
- Chemical Laboratory
- Washing Room
The brief description of all the above rooms is discussed below:-
3.1 MAIN LABORATORY:
In this room instruments for routine analysis are present. i.e. Dissolution apparatus, Disintegration apparatus, melting point apparatus and other instruments. In front of the entrance, there is a table of Quality Control Manager. Computer and other routine files are present on this table. Three marble racks are present in this room, i.e. left side to the entrance, right side of the room and front side of the room. Underneath of these racks there are cupboards for general purpose.
One right side of the wall there are cupboards hanged with the walls. General records and files are stored in these cupboards.
3.2 MICROBIOLOGY LABORATORY:
This room has one marble rack on left side of the room. The cupboard under the rack is for miscellaneous use.
Instruments used for microbiological testing are present in this room i.e. cooled incubator, Laminar flow, heating oven, hot incubator and microscope etc.
Above the rack there are some reagents and solutions for microbiological work.
3.3 BUFFER AREA:
This area is used for the entrance to the microbiology room.
3.4 RECORD ROOM:
On front side of this room there is a marble rack
3.5 INSTRUMENT ROOM:
This room has three marble racks. All sensitive instrument i.e. HPLC, UV, etc. are placed on all these three racks. Cupboards below these racks contains related accessories of the instruments. Finished product samples after testing is placed in these cupboards.
3.6 WASHING AND CHEMICAL STORAGE ROOM:
This room is used for washing of glass apparatus and other general washing purposes.
This room also contain a fuming hood, marble racks and cupboards below the racks. On these rack titration stands, burettes, pipettes, reagents, volumetric and test solutions are placed. Cupboard under the racks are used for storage of chemicals, volumetric solutions and reagents.
3.7 RETAINED SAMPLES ROOM:
This room is present on end left side of chemical lab. There are iron racks which contain Retained samples of Finished Product, raw materials, packaging materials, empty bottles for Retained samples of raw materials.
AIR CONDITIONING SYSTEM
Quality Control Department is air conditioned by separate split air conditioning system to maintain temperature between 15-300C as a working temperature.
5.1 PERIODICAL TRAINING:
The staff responsible for performance of this operating instruction has to be demonstrated periodically about the content of this SOP.
5.2 TRAINING FOR NEW EMPLOYEES:
Before starting with the job, the employee has to be demonstrated about the content of this SOP.