SOP Title: Equipment & Machinery Maintenance
- Objective:
To lay down procedure for preventive maintenance requirement and providing effective maintenance to machinery/equipments in the facility to ensure proper functioning.
- Scope: This procedure is applicable to:
- Installation of new machinery and complete trial.
- Routine breakdown maintenance.
- Periodical preventive maintenance.
- Periodical servicing of the machinery/equipment.
- Responsibility:
Head Concerned Department: Shall be responsible for identifying the requirement of maintenance as per schedule and compliance thereof.
Head Engineering: Shall be responsible for the timely execution of the maintenance and maintaining records thereof.
Plant Head: Shall be responsible for approval of the machinery and spares requirement and purchase thereof.
Head QA: Shall be responsible for preparing and approval of maintenance procedure and ensuring compliance thereof.
- Accountability:
Head QA, Engineering and Concerned Department.
- Procedure:
5.1 Definitions:
Preventive Maintenance: Preventative Maintenance is maintenance that is regularly performed on a piece of equipment to lessen the likelihood of it failing. Preventative maintenance is performed while the equipment is still working, so that it does not break down unexpectedly.
Breakdown Maintenance: Breakdown maintenance is maintenance performed on equipment that has broken down or proper working/operation stopped unexpectedly.
Concerned Department: Department in which the equipment or machinery is installed and operated and maintenance responsibility lies with.
5.2 Procedure:
| 5.2.1 | Maintenance Program: Maintenance program shall include following aspects: | |
| 5.2.1.1 | Equipment used in manufacturing, processing, testing, packaging and holding of drug product where applicable. | |
| 5.2.1.2 | Provisions shall be made for notification to Concerned Department for maintenance schedule. | |
| 5.2.1.3 | Maintenance operation should not compromise product quality. | |
| 5.2.1.4 | Mechanism for production supervision to notify maintenance of potential problems. | |
| 5.2.1.5 | Mechanism for Engineering to notify maintenance requirements/ spares to rectify/prevent potential problems. | |
| 5.2.1.6 | Type of maintenance work required i.e. electrical, mechanical and civil. | |
| 5.2.2. | Maintenance Procedure | |
| 5.2.2.1 | All machines shall be provided with Log Book, wherein the operational status of the machinery is recorded. | |
| 5.2.2.2 | Whenever a breakdown occurs, a complaint note in complaint format shall be sent to the Engineering Department. | |
| 5.2.2.3 | All general maintenance jobs shall be performed as per written procedure. | |
| 5.2.2.4 | After completion of the maintenance job, the complainant shall sign the copy of the complaint note, in proof thereof. | |
| 5.2.2.5 | If spares are required, proper indent shall be given to Stores (Maintenance). | |
| 5.2.2.6 | Periodical maintenance and servicing of the machinery shall be done as per written procedure. Preventive maintenance schedule shall be prepared for all process equipment / machinery and records maintained, following written procedure. | |
| 5.2.2.7 | Machines, which are under annual maintenance contract, shall be repaired by the concerned agency as specified in the list of approved service contractors. | |
| 5.2.2.8 | Civil maintenance is done periodically under the supervision of Head Administration | |
| 5.2.2.9 | Records for the repairs, servicing etc., as and when required, in the Machine Maintenance and Service Records. | |
| 5.2.2.10 | All critical equipment including LAF, sampling and dispensing booths, balances, HVAC, boilers, RO-EDI water plant, dehumidifiers, stability chambers and compressors are maintained under annual service maintenance contract. | |
- Abbreviation:
| Abbreviation | Expansion |
| HVAC | Heating, Ventilation and Air Conditioning |
| LAF | Laminar Air Flow |
| i.e. | Id Est (that is) |
*Note – Ready to use SOP available in “DOWNLOAD” Section.