sop for for Qualification Planner
To lay down a Procedure for Qualification Planner.
This SOP is applicable for Qualification Planner of all the Equipment/Area handled and Qualified
6.0 PROCEDURE: PRECAUTION:
Do not use non Qualified Equipment / Area.
6.1 EQUIPMENTS/AREA – QUALIFICATION:
6.1.1 Manufacturing equipment shall be qualified for intended use and shall be assigned
with a unique ID. No. as its identity. QA Department is responsible for assigning
the ID.Number independently for all equipment and utility.
6.1.2 Qualification team i.e. Quality Assurance, Production, Quality Control and Engineering
Department along with vendor (manufacturer)(where applicable)shall qualify the equipment
installed in the Production area & warehouse and identify the Equipment “Equipment
Qualification Status Label” as Annexure-I.
6.1.3 Qualification protocol contains the procedures, Frequency and Acceptance Criteria and precautions and to be followed the same.
6.1.4 Qualification of equipment / area, done at defined frequency. However,
when equipment is in operation and / or for any other reasons Qualification could not be done at due
Period, it must be qualified under the tolerance period as mention accordingly:
Qualification Set Frequency Tolerance
Production Equipment Half year ,1 & 2 Years ±One Month
Area Qualification / HVAC Half Yearly,1 & 2 Years ± One Month
Utility Yearly ± One Month
Due to any reason, if Qualification due date exceeds the delay in Qualification shall be approved by Head QA.
6.1.5 Any Qualification done by external person / agency shall be recorded and maintained with its relevant record.
The Officer / Executive in qualification team shall ensures the equipment is Qualified before putting into operation.
6.1.6 A Master Qualification Planner shall be maintained for all the equipment’s / Area as shown in
Annexure-II for Periodic Qualification of Calendar year.
6.1.7 The first column of the Annexure-II i.e. “Name of Area” shall have only name of the main core area specially in case of AHUs.
6.1.8 The first Planner of the year shall have a revision no. as 00 and whenever
there will be any changes in the planner due to addition / deletion or any reason,
the revision no. shall be changed accordingly to next revision no. during the same year.
6.1.9 For routine Qualification, either Annual Contract or Annual Arrangement shall be
made with Equipment manufacturer / Authorized Agent. Frequency of Qualification
shall be followed as per the contract. A Qualification Protocol & Report
shall be maintained by the Quality Assurance Department.
6.1.10 For routine servicing and maintenance, either Annual service
contract or service arrangement shall be made with Equipment manufacturer / authorized Service agent.
Frequency of servicing shall be followed as per the contract. A service report shall be maintained by the respective Department.
SOP Standard Operating process QA Quality Assurance
ID Identification AHU Air Handling Unit
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Annexure-I Equipment Qualification Status
Annexure-II Master Qualification Planner Execution Record
Annexure-III Under Requalification status
Master Copy Quality Assurance Department.
Controlled Copy No. 01 Quality Assurance Department.
Controlled Copy No. 02 Quality Control Department.
Validation Master Plan WHO
11.0 REVISION HISTORY:
|Revision No.||Change Control No.||Details of Changes||Reason of Changes||Effective Date||Done By|