Blog

Standard Operating Procedure (SOP) and Guideline for handling the breakdown maintenance of Instrument, Equipment, System and Utilities in pharmaceutical Drug Manufacturing Plant.

Breakdown Maintenance System

1.0   Purpose :

• • To define procedure for Breakdown Maintenance System.

2.0   Scope :   

• • This guideline is applicable to maintenance of all Equipment or Machine.

3.0   Reference, Attachments and Annexures :

• • References :

• • 21 CFR 58 : Subpart D : Equipment

• • 21 CFR 182 : Equipment Cleaning and Use Log

• • SOP – Handling Procedure of Corrective and Preventive Action (CAPA) 

• • Guideline – Change Control Management

• • Attachments :

• • Under Breakdown Maintenance Label – Attachment-1.

• • Breakdown Maintenance Report – Attachment-2.

• • Breakdown Maintenance Register – Attachment-3.

• • Equipment History Card – Attachment-4.

4.0   Responsibility – Breakdown Maintenance:

• • Concern Department shall be responsible for :

• • Report equipment malfunctioning or breakdown to a Engineering department and QA through breakdown maintenance report.

• • Intimate Quality Assurance department for breakdown and impact analysis / further actionable.

• • Put the status label on the subjected equipment as “Under Maintenance”.

• • Check the performance / evaluate the equipment, after completion of maintenance work.

• • Make entry in breakdown maintenance register and sequential log.

• • Engineering Department shall be responsible for :

• • Receive the maintenance report and carry out the maintenance of the subjected equipment.

• • Evaluate the need of filing planned modification as per the guideline of planned modification.

• • Evaluate the reason for breakdown and rectify the problem.

• • Provide the use trial (if required) to the user department while hand-over.

• • Maintain proper records of maintenance done.

• • Update equipment history card.

• • Quality Assurance Department shall be responsible for :

• • Ensure that proper records are maintained.

• • Evaluate whether breakdown or it’s maintenance triggers event, change control or planned modification filing.

• • Recommend impact analysis and ensure that the actionable and recommendations are closed.

• • Evaluate and decide disposition / further operation of product(s) / batch(s) under impact.

• • Evaluate and decide the equipment shall be allowed to further use.

5.0   Definition of terms & abbreviations  – Breakdown Maintenance:

• • Repetitive Equipment/Machine Breakdowns

• • The same breakdown occurring in equipment/machine more than once in same product/ different product batches during same process.

• • If the same equipment failure / process parameter out of limit occurring in same equipment more than once. e.g. temperature out of limit during process  monitoring, lyophilization, coating process etc.

• • The same equipment failure / process parameter out of limit occurring in different equipment / machine due to a common utility problem. e.g. cooling zone temperature out of limit in different tunnels.

• • Corrective Action

• • A corrective action refers to the repair, rework or adjustment made, action taken to the product as part of the disposition of an existing nonconformity.

• • Preventive Action

• • A preventive action is an action taken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent its re-occurrence.

• • Like to Like Replacement

• • Like to like replacement means component / equipment / part either of same make, same model or same technical specification.

• • Abbreviations :

• • CAPA: Corrective and Preventive Action

• • CFR: Code of Federal Regulations

• • PMF: Planned Modification Form

6.0   Procedure for Breakdown Maintenance:

• • Control of Breakdown Maintenance Log Book:

• • The log book having printed page numbers/ breakdown maintenance serial numbers as defined below shall be issued to each user department by QA and issuance record of the same shall be maintained by QA. (Refer Attachment-3)

• • The maintenance no. for the each breakdown maintenance report shall be given like TAB/12/0001 in which –

• • • First three letters shall represent department name (e.g. TAB for Tablet),

• • • Next two digits shall represent year (e.g. 12 for year 2012) and

• • • Last four digits (e.g. 0001) shall represent number of breakdown maintenance occurred in that department.

Note: This numbering system is for guidance purpose only and maintenance numbering can be changed if required.

• • Execution of Maintenance :

• • In-case of equipment, machine or utility breakdown, the concern department shall label it with “under maintenance” status label as per Attachment-1.

• Section-1 (Intimation)-To be filled by Concern Department

• • Following details shall be filled in breakdown maintenance report by concern person and shall be informed to Concern Department Head (Refer Attachment-2).

• • Maintenance no. : Mention as explained above.

• • Fill up the department name and date and time of breakdown.

• • Mention the name of the equipment / instrument / utility, code number and location of the equipment / instrument / utility which is under breakdown.

• • Describe the nature of the problem. Also mention the problem is related to electrical or mechanical if possible.

• • Specify the product and batch(es) under impact if the breakdown has occurred while processing the product.

• • Person from user department shall forward the “Breakdown Maintenance Report” to Departmental Head or Designee for his remark.

• • Department Head may specify if any special precautions are to be taken while carrying out the maintenance.
  • The Department Head shall also ensure that the information is given to QA and QA shall sign the breakdown maintenance report.

• Section-2 (For Engineering)-To be filled by Engineering Department :

• • The breakdown maintenance report shall be forwarded to concern person in Engineering department according to the nature of the problem.

• • While receiving the breakdown maintenance report, Engineering supervisor shall check the details filled in the breakdown maintenance report.

• • After verifying completeness of the details, Engineering supervisor shall sign the breakdown maintenance report with date and time as an intimation received and arrange to attend the breakdown.

• • After receiving breakdown maintenance report Engineering shall mention the reason for breakdown and mention whether it is repetitive breakdown for the same equipment, machine or utility based on evaluating equipment history card.

• • The Engineering person shall review necessity of work and depute engineer and technician for work.

• • Technician shall carry out the maintenance under the supervision of maintenance engineer (if required).

• • Details of maintenance work to be carried out shall be mentioned in the breakdown maintenance report in section 2 by Engineering department person.

• • This shall be approved by user department.

• • After approval from user department maintenance work shall be carried out.

• • The details shall be mentioned in corrective actions taken in section 2.

• • The person who carried out this corrective action shall sign the breakdown maintenance report.

• • During maintenance if any part found damage then to change the damaged part, planned modification shall be raised only if like to like parts are not available.

• • The Engineering department shall also evaluate requirement for Passivation, Cleaning, Sanitization, Re-calibration, Re-qualification, Planned Modification based on maintenance done for breakdown rectification.

• • The equipment history card shall be updated for the details after completion of the activity and breakdown maintenance report shall be signed.

• • Incase of repetitive breakdowns found then preventative maintenance frequency / schedule may be revised.

• • While handing over the equipment, Engineering supervisor and the person receiving the equipment from the user department shall ensure the completion of the job and sign the report with date and time.

• • If required, running trials shall be given to the user department, while handing over the equipment.

• • The equipment history card (Refer attachment-4) shall be updated by Engineering department.

Note: Incase of any changes / modifications / part replacements done during the preventive maintenance, the same shall also be recorded in equipment’s history card and QA shall be informed for impact analysis study. 

• Section-3 (For Quality Assurance)-To be filled by Quality Assurance Department

• • Prior to handing over the equipment / utility to concern department, the breakdown maintenance report shall be forwarded to QA to recommend impact analysis.

• • QA shall provide remarks and recommend impact analysis based on review of nature / reason for breakdown and breakdown maintenance details.

• • Quality Assurance shall decide whether the breakdown or it’s maintenance triggers event, change control or planned modification filing.

• • QA shall allot investigation incase of,

• • • Repetitive breakdown.

• • • If any batch is under manufacturing while breakdown (to evaluate the impact on product quality)

• • QA shall also review and concur the correctness for evaluation of further actionable suggested in the section 2 filled by Engineering department.

• Section-4 (For Concern Department)-To be filled by Concern Department

• • The concern department shall sign the maintenance report for receipt of the machine / equipment / utility after rectification and after verify the maintenance work done Engineering as well as evaluate the machine / equipment / utility for their desired performance.

• • The concern department shall also evaluate need for Passivation, Cleaning, Sanitization, Re-calibration, Re-qualification and specify the respective reference for the same in breakdown maintenance report.

• • The equipment breakdown maintenance register shall be updated accordingly by concern department.(Refer attachment-3).

• Section-5 (For Quality Assurance)-To be filled by Quality Assurance Department

• • QA shall ensure that all action suggested in the different sections of the report are completed and wherever not completed, shall issue CAPA number (corrective and preventive action) and monitor the same.

• • QA shall allot change control number for changes suggested if any in investigation report. (For example, incase of repetitive breakdowns, if increase in preventive maintenance or calibration frequency is suggested).

• • QA shall verify and record following status but not limited to,

• • • Event status,

• • • Planed modification (PMF) status,

• • • Investigation status,

• • • Change control status,

• • • Re-qualification / Re-calibration status,

• • • Cleaning / Sanitization status,

• • • CAPA No.,

• • • Batch disposition status,

• • • Impact evaluation status,

• • • Based on review of breakdown maintenance report and QA shall release the machine/ equipment for further use.

Attachment – 1 : Under Breakdown Maintenance Label

Attachment-2 : Breakdown Maintenance Report

 Attachment-3 – Breakdown Maintenance Register

Attachment-4 : Equipment History Card

Date & Time : _________________

********************************************END********************************************