Calibration Procedure for Pharmaceutical Industries

Calibration Procedure for Pharmaceutical Industries

1.        Scope :- This procedure applies to the Process/ Manufacturing and laboratory equipment used by the Pharmaceutical Industries.

2.        Purpose :-  The Purpose of  procedure specifies the schedule and requirements for calibration, performance verification, and maintenance of Laboratory, Process/ Manufacturing  testing instruments and equipment.

3.        Roles and Responsibility :-

A.    User Department :- User Department Ensure the Equipment/ Instrument Availability of the System as Desired Instrument List.

B.    QA Engineering Department: -  is Responsible for Preparing, Implementing and Maintaining the Procedure. And Review the Instrument/ Equipment Planner and Check the Calibration Row Data and Calibration Certificate as per Desired Point.

C.     Calibration Owner: -  is Responsible for Following the Procedure as  per Approve Procedure.

D.    QA Department: - QA Department is Responsible for Assigned Calibration Owner and User Department responsibility as per the Defined Procedure.

 

4.     Terms and Definition

 

4.1     Calibration :- Calibration is Procedure for Adjustment or standardization of the accuracy of a measuring instrument, usually by comparison with a certified reference or standard.

4.2     Traceability:-  The linking of measurement standards and/or measuring instruments to relevant national or international standards through an unbroken chain of comparisons.

4.3     Like to Like :- The instrument which has same specification like Least Count, Accuracy, Range, and Process connection.

4.4      Calibration Range :-   Measurement range of the instrument for which calibration has been / is to be carried out.

4.5     Least Count :- Measurable Small Unit is Least Count.

 

4.6     Out of Calibration:-  Instrument is Working Condition and Found Instrument Out Side the Accuracy ,Beyond the Limit.

4.7     Criticality Assessment :- He process of evaluating the impact of operating, controlling, alarming and failure conditions of a system on the quality of a product Basically Instrument Divided into Three Category a. Critical b. Non Critical c. For Information

4.8     Critical Instrument: - Impact on Direct Production Process.

4.9     Non  Critical Instrument :- No Impact on Production Process.

4.10               For Information :- No Directly and Indirectly Impact on Production Process, Only on Only Indicative Purpose.

 

5.           Procedure:-

Adding Procedure for New Instrument/Equipment

5.1     Rise the Change Control Procedure: - Defined the Why /Where We are Install a Equipment and General Aspect full fill as per Approved Change Control Procedure.

 

5.2  Criticality Assessment: - Defined the Instrument Criticality Assessment as Desired Process Parameter. After Assessment Defined the Instrument category.

 

5.3     Assign the Equipment and Instrument Identification Number. After Installation of Equipment and Instrument as Per Criticality Assessment Assigning the Unique Identification no. for Each and Every Instrument. Numbering System Assign as per Equipment Numbering Sop.

 

5.4  Defined Calibration Frequency: - Defined the Calibration Frequency as Per Criticality Assessment. General Terms of Define the Frequency

 

Sr. No.	Instrument Category	Frequency	Tolerance
1.	Critical	6 Month	+/- 30 Days
2	Non Critical	12 Month	+/- 30 Days
3	For Information	No Need As Requirement	NA
4	Master Instrument	12 Month	+/- 60 Days

 

5.6  Prepare Calibration Master Plan :-  After identification of the Instrument and Categorization and Frequency  That Instrument Shall be Add in  Calibration Master Plan. CML Should be Revised in Every Once in Year.

 

5.7  Prepare Calibration Schedule :- The schedule which defines the frequency  after which the instrument should be calibrated.

 

6.                 DETAILS OF PROCEDURE

6.1 General Equipment Requirements

The QA Manager or designee shall maintain an equipment inventory that shall include the following information:

A.   Sr. No

B.    Instrument ID

C.     Instrument Location

D.   Accuracy

E.     Acceptance Criteria

F.     Category

G.    Remark

H.   History

I.      Remark

 

6.1.1                  If any Instrument Added and Delete and Modified, Prepare the Addendum of Instrument Manufacturing List With Respect to Change Control

6.1.2                Instrument List Shall be Revised in Once in a year.

6.1.3                All equipment in the equipment inventory system shall be identified uniquely.

6.1.4                All equipment shall be maintained in good operating order and according to the manufacturer and/or Section maintenance requirements.

6.1.5                 All critical equipment shall be calibrated or verified before use.

 

6.2  Master Standards

6.2.1                Whenever possible, Master standards traceable to SI units (International System of Units) shall be used. In situations where SI units cannot be used, certified reference material provided by a competent supplier shall be used if available.

6.2.2               Master standards shall be calibrated by an accredited organization or vendor that can provide proof of traceability. These typically would include, but not be limited to, ISO 17025-certified companies.

6.2.3               Reference standards shall only be handled by employees authorized by the QA Manager/Supervisor and shall be stored to prevent contamination and/or deterioration. Reference standards shall be calibrated before and after any adjustment. All reference standards, certified reference materials, or reference materials used for calibration shall be uniquely identified. A certificate of traceability, if applicable, shall be retained to ensure traceability.

6.2.4               QA Managers/Supervisors shall include procedures for calibration and/or performance verification of new equipment in Section technical procedures.

6.2.5               calibration procedures shall be appropriate for the intended use of the equipment and shall provide criteria for determining if calibration is satisfactory.

6.2.6               Calibration records shall be maintained and associated with the unique identifier of each piece of equipment. These records shall include:

 

·        the identity of the item of equipment.

·        Name of manufacturer.

·        Serial number or unique identifier.

·        Date of calibration.

·        Current location.

·        Manufacturer’s instructions for Useable Instrument 

·        The reference standard certified reference material or reference material used for calibration.

·        Copies of all reports, results of calibration, and/or certificates of calibration.

·        A maintenance plan and due date for the next calibration.

·        The identity of the individual performing calibration.

 

6.2.7               When external calibrations are performed, service providers that demonstrate competence, measurement capability, and traceability shall be used. Calibration certificates from these providers shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification. When possible, providers accredited to ISO 17025 shall be used. Copies of the provider’s accreditation documentation shall be maintained by the Quality Engineering (QE).

6.2.8               If calibrations are performed by an outside vendor, the Section document control custodian shall maintain the original calibration records provided by the vendor and a copy of the relevant records shall be readily available.

6.2.9               Laboratory equipment requiring calibration shall be labelled or coded to indicate the calibration status, including the date when last calibrated and the due date for recalibration (or expiration criteria for when recalibration is due).

6.3     Out of Service Instrument :-

6.3.1                Equipment that has been subjected to overloading or mishandling, gives suspect results or has been shown to be defective or outside specified limits, shall be taken out of service. It shall be isolated and/or clearly labelled (Out of Service – Do Not Use) to prevent use until repaired and shown by calibration or test to perform correctly.

6.3.2                Prior to returning a piece of equipment to use (out of service for any reason – e.g., maintenance, malfunction, leaving the direct control of the Laboratory), the correct operation shall be demonstrated by calibration or performance verification. Laboratory personnel shall examine the effect(s), if any, of a malfunction on analysis results and implement the Procedure for Corrective Action as required.

6.4              out of schedule:-

6.4.1              If calibration is not performed within the scheduled due date, an Incident notification shall be raised & investigation shall be carried out and details of investigation shall be documented.

6.5           unavailable for calibration :-

6.5.1                 If an equipment/instrument is under validation/Major maintenance/Breakdown etc. then Calibration shall not be performed & calibration order shall be locked with reference document / notification number.

 

6.6          Adding/Deleting/Removing/Modification :-

6.6.1                If any Case Instrument Shall be Removed from Equipment, CML to be Update as per Desired Format and Also Mention the Remark Reference Change Control or Document No. And Also Update the Calibration Schedule.

6.6.2               If any Case Instrument Shall be Add from Equipment, CML to be Update as per Desired Format and Also Mention the Remark Reference Change Control or Document No. And Also Update the Calibration Schedule.

6.6.3               If any Case Instrument Shall be Modify (Range, Location, Least Count ..Etc) from Equipment, CML to be Update as per Desired Format and Also Mention the Remark Reference Change Control or Document No. And Also Update the Calibration Schedule.

 

 

Annexure-I Instrument Criticaility Assesment
Equipment Name
Equipment ID
Assesment Point		Equipment ID		Equipment ID
		Impact		Non Impact
		Yes	No	Yes	No
Does the system automate or control any of: Manufacturing, Sterilization, Formulation, Labeling, Inventory, or Critical Environment Controls?
Is the system the original source of data for the automation or control of any of: Manufacturing, Sterilization, Formulation, Labeling, Inventory, or Critical Environment Controls?
Is this system used to generate, manage and analyze data concerning Product Quality, Safety, Efficacy, Strength Stability or identify?
Is this system used for raw and in-process material, clinical data analysis, automated inspection equipment and laboratory data system?
Is this system used for cGxP Support Functions like Calibration, Maintenance Scheduling, Quality Trending?
Is this system used for market complaints or adverse event reporting? / electronic document submission/reporting to regulatory agencies
Is this system used to handle CAPA, Change Control, Incident, Audit, testing, lab event?
Is this system used to maintain records of training of personnel?
Is the system used to maintain copies of protocol pertaining to non-clinical study?

 

 

If One Point are yes Instrument is Critical Otherwise Instrument Will be Non Critical.