Assigning of laboratory control number; Purpose
The tenacity of this SOP is to define the procedure of assigning Laboratory control number (Lab. Control No.) of all type raw material, packaging material, water, intermediate, bulk and finished product that are analyzed in Quality Control and Microbiology Laboratory.
Assigning of laboratory control number; Scope
This procedure is applicable for all type of raw materials, packaging materials, water, intermediate, bulk and finished products of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[] GRN: Goods Received Note
[] Lab. Control No.: A system of alpha-numerical number which represents request for analysis of materials/ water/ products received from respective department.
[] QC: Quality Control.
[] SAF: Sampling Advice Form
Responsibilities
The roles and responsibility is as follows:
[] Sr. Executive/Executive, Quality Control & Microbiology
[] To confirm that this procedure is followed.
[] To maintain the records properly as per SOP.
Assistant Manager, Quality Control
[] To confirm that this procedure is kept up to date.
[] To check that the SOP reflects the required working practices.
[] Organize training on the SOP to all concerned personnel.
[] To confirm implementation of the SOP after training.
Head of Quality Assurance
[] To ensure the overall implementation of the SOP.
[] Take initiative to Approval of the SOP.
Procedure:
[] All newly delivered samples & the accompanying documents (e.g. test request) must be assigned a separate registration number.
[] Assign Laboratory control number (Lab. Control No.) in following way:
Put first two or three letters according to the abbreviations mentioned below –
- BBW Boiler Blowdown Water
- BFW Boiler Feed Water
- CTW Cooling Tower Water
- DW Drinking Water
- EM Environment Monitoring
- ET Endotoxin Test
- ETP Effluent Treatment Water
- FP Bulk Product (Semi-Finished)
- GMB General Microbiology
- PM Packaging Material
- PMS Packaging Material of Source Approval
- PSC Purified Steam Condensate
- PTW Potable Water
- PW Purified Water
- RM Raw Material
- RMS Raw Material of Source Approval
- SHC Sodium Hypochlorite
- ST Sterility Test
- STB Stability Sample
- WFI Water for Injection
- WW Wash Water
Write down a hyphen (-) after the abbreviation, then serial number consist of three digits i.e. 001, then a slash and put two digits of month i.e. 08 for month August.
Again write down a slash (/) then last two digits of the year i.e. XX for year 20XX. For example, first raw material received on August 20XX will get the Lab. Control No.: RM-001/08/XX.
GMB will be included before abbreviation of each test in case of microbiology lab control no./lab reference no. and put slash (/) after that.
Record Lab. Control No. in Register against each GRN / SAF.
Record the same in respective documents and status label also.