top of page

GMP claiming problems facing maintenance departments of pharmaceutical operations

Preventive Maintenance challenges in Pharmaceutical Industries, and available solutions. (Part2)

In part one of this article, we discussed the particularities of Maintenance in the pharmaceutical industries. Here below are the top 8 challenges facing maintenance departments of the industry.

here are the problems that will cause you grief when an auditor arrives. It is recommended that you identify, investigate, and fix them before the auditor's next visit.

1. Maintenance plans are not risk-based.

When it comes to maintenance, often every piece

of equipment within the plant is treated equally. A better way is to use a risk-based approach that classifies each piece of equipment in terms of its impact on product patient safety.

Such an approach may seem time-consuming at the beginning, but it ultimately focuses your maintenance efforts and budget where it matters the most for your product's quality and safety of the patient.

2. Maintenance plans are not updated.

Updating the maintenance plan is not often considered to be included as an activity in the procedure covering new equipment installation. In many cases, several copies of the maintenance plan exist and in different formats, which adds to the complexity of keeping it up to date.

Buying new advanced technology equipment is very exciting, but we often forget that this beauty must be maintained.

3. Maintenance staff are not well trained on cGMP documentation practices.

Let’s face it- Maintenance staff would rather be doing hands-on work for 10 straight hours than completing the paperwork. It’s hard enough to get them to complete maintenance records, let alone Change Control forms and investigations. Yet simple maintenance activities such as changing filters or adding lubricant can dramatically impact product quality.

Training is a crucial factor but making

documentation more structured and easier has a very positive effect to keep up with good documentation practices. The auditors will ask staff to “show me,” so if the documentation says that you do it, they will ask to see proof of it. They have a well-trained eye to detect impractical systems and drill down. You don’t want to be at the bottom of the drilling.

4. Maintenance of utilities and non-production equipment falls between departmental cracks.

Non-production equipment is often neglected and is not clear who is responsible for what.

Power supplies, fire protection systems, security systems, HVAC, water, and gas

supplies always falling behind their maintenance schedules and the finger-pointing game starts when things go wrong.

These items are usually ranked as less likely to fail, however, if it happens, the impact is wider and harder to point out.

5. Non-scheduled maintenance and repairs are poorly documented.

In the rush of the day, Maintenance technicians receive several requests to verify, maintain and repair different equipment out of their schedule.

These requests can be passed on to the technician by small talks in the hallway or cafeteria, shown up on their desks as colourful post-its (which are often not readable!), phone calls, e-mails, etc.

The majority of these will be faded as the technician is walking across the plant. Some that are not completely blown, and end up being squeezed between other tasks, will be patched up without almost any documentation. Evaluating their impact on production batches-Forget it!

An easy-to-access structured way of communication is essential to capture all these events that are an important part of any equipment life cycle.

6. The equipment documentation should be in the hands of the maintenance technician before starting work, including:

· The manufacturer’s operation manual

· The manufacturer’s installation manual

· The manufacturer’s service manual

· Details of the validated state of the equipment

· Any maintenance records.

· Any work instructions or procedures covering the use of the equipment.

· Engineering drawings

· Process and instrument diagrams

Unfortunately, this is far from being the case in many pharmaceutical operations.

Often the equipment documents are dispersed to some paper documents, excel worksheets, PDF files on network locations and internet links.

The ideal system would be to have controlled electronic copies of all these documents that the technician calls up from a wireless device.

An auditor typically selects three pieces of product-critical equipment and asks to see the maintenance records for them. You better have them readily accessible with complete and accurate and updated information.

An adequate Computerized Maintenance Management Software typically performs five GMP-critical tasks:

· Allocating a unique identification number to each piece of equipment

· Being the depository of maintenance plans

· Holding records of maintenance activities

· Scheduling maintenance activities and necessary approvals

· Structuring non-scheduled maintenance and repair request (Adhocs)

· Maintain the integrity of equipment documentation, maintenance plans and their execution, and their accessibility throughout the equipment lifecycle.

CMMS is the ideal way to keep a single source detailed maintenance plan. It is easy to update, and the updated plan immediately affects the maintenance schedules. It highly facilitates the proper documentation of the interventions, as much of the lengthy information is pre-loaded to the system, critical information is mandatory to be filled, and many fields are prepopulated with pre-defined choices and other easy-to-use controls like date/time pickers.

The possibility of assigning the different types of maintenance to groups, plants, and locations, makes it easy to plan and keep up with the non-production equipment maintenance.

An adequate CMMS also provides a structured way for the operators to communicate the non-scheduled maintenance requests to the maintenance team and instantly being informed of the status of their request. The well-structured requests have the necessary information and will be treated the same way as scheduled maintenance with proper documentation. No more Faded request!

One of the most important benefits of using a CMMS is that a technician has immediate access to the chronological history of interventions for any instrument, which helps the diagnosis, and problem-solving and builds up the technical knowledge as it goes.

The traceability of all maintenance interventions is an indisputable parameter that helps investigators to better understand the chain of events, determining root causes and ultimately accelerates closing the investigations. It also helps to build more effective CAPA and measuring their efficiency.

Last but not the least, Managers benefit from CMMS instant reports that lead to making informed and timely decisions to support the production and its quality.

And the list can go on!

The third part of this article will be published shortly to discuss “The biggest challenge of selection and integration of CMMS in Pharma Industry”.


bottom of page