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GMP in pharma needs a strong dose of FM

India is a pharmacy to the world.
The Indian pharmaceutical industry is the world’s third-largest by volume and 14th largest in terms of value. The country exported pharmaceuticals worth `1,75,040 crore in FY 2021-22, including bulk drugs/drug intermediates.
Lately, however, this industry has been in the news for the wrong reasons. Reports of substandard products from more than one manufacturer being recalled from more than one country have reached the common man, and threaten to tarnish the reputation of this essential sector.
While regulatory authorities are investigating the lapses, initial reports say that the manufacturing conditions inside pharma factories were less than ideal. Good Manufacturing Practices (GMP) are already mandatory for companies exporting their products; the latest slip-ups indicate that these norms need to be tightened, and monitored more stringently. This covers all aspects of production – from the starting materials, premises and equipment to the training and personal hygiene of staff.

At the time of the writing, a news article quotes a government source to reveal that the Union government is likely to make GMP mandatory for all units manufacturing drugs in the country, not just for those which cater to the export market. This is a welcome step. Many more are needed.
In this month’s cover story, Clean India Journal shines a spotlight on facility management in the pharma sector – from challenges and best practices to innovative solutions and waste management.
Who better than FM heads, plant heads and admin heads from the pharma industry to talk about their best practices, challenges, processes and other trade secrets? Here is an analysis of Clean India Journal’s interaction with three of them, as well as their views, in their own words.

Consistent manpower

During the pandemic, the pharma sector faced a manpower crunch that led to unfortunate consequences. The lack of skilled power for maintenance of the production facility led to deterioration in the condition of assets. Understandably, all three respondents place consistent availability of manpower at the centre of facility management.

Constrained budgets

There is a lot of push from the management to reduce costs across the board. One consequence of this is that the subsidisation of employee services is being rationalised.

Earlier, manufacturing facilities were located 40-50 km away from the nearest city, and employees found it difficult to commute to and from work. Shared office buses and cabs came up as a solution. Today, most such facilities are on the outskirts of urban centres, and more transport options exist. Employee services will remain, but the employee will also have to contribute to them.

For a service that costs ₹100 (for example), no longer will the organisation contribute ₹99. With rational contributions from employees, FM will be able to continue providing employee services within the existing budget.

Budget planning

If the company is expanding, FM will also have to increase. This is forecasted based on headcounts, and accordingly, the cost is calculated. Statutory inflation has to be accounted for. The minimum wage for unskilled, semi-skilled and skilled manpower is also set by the government; one should account for a 4-5% increase every year.

If the facility manager wants to sustain within the existing budget, they will have to find ways to reduce FM headcount by optimising their space utilisation, or going for solutions like robotic cleaning.

Clean room maintenance

When a pharma company commits to a regulatory body that it manufactures the products it markets and uses its own employees to do so, outsourcing clean room maintenance to an external agency becomes tricky. However, the technically qualified team of the pharma manufacturer is not equipped to clean and mop the facility themselves. Instead, skilled outsourced labour works under their direct supervision.

Skilling challenges

One of our respondents said: “Since even professional FM providers hire locally, their performance is similar to that of a local agency. Subcontracting is another issue; with multiple levels of subcontracting, our ability to control quality spirals down.”

Unskilled manpower in pharma FM is simply not an option. Without training, no worker can or should be deployed to a pharma facility.

The same challenge exists in pest management. While the vendor may have invested in R&D to define which chemical should be used for what pest, their field representatives may not be trained enough to transfer that domain knowledge to pest management at the pharma facility.

Costs

There are high costs associated with procuring and maintaining cleaning machines. Apart from this, some FM heads believe that the 10-15% management fee charged by professional FM vendors is not justified by the level of service delivered by unskilled/semi-skilled ground teams.

Digitalisation

Despite being a manufacturing industry that relies on heavy, sophisticated and expensive machinery, when it came to facility management, plant heads still had to negotiate old-school processes for documentation and service requests. Not any more.

Saurabh Jha, Sr Manager – Administration, Lupin Pharma

Security innovation

In pharma, cross-contamination is a major issue. Thousands of people come to the facility every day, potentially bringing contaminants with them, even into the clean room, which is just not permissible. Each person needed to be frisked at the entry point. But during the pandemic, we wanted to avoid close physical contact.

We worked with a manufacturer to develop a special hand-held metal detector that security personnel can use to detect cigarettes or gutkha pouches on a person, without having to make physical contact. The device sends out a different sound when each is detected — a more graceful method of frisking. With this, we have also been able to scale down our security headcount, thus also saving on spends.

With the innovations we have introduced, we have been able to save on almost 10% of our annual budget.

Less manpower, more tech

Many service providers are providing us with the option of upgrading from manual/conventional machines to AI-driven machines that enable contactless cleaning.

However, there are some obstacles in the way of adopting robotics.

Manufacturers of such machines need to take the unique dynamics of a pharma manufacturing facility into consideration. Programmable machines are supposed to simplify cleaning, but in pharma, this programme/schedule changes every other hour. For example, unscheduled extensive cleaning may suddenly be required; it may have been scheduled for later but is suddenly required immediately. Or just a part of the area may need to be cleaned. For this reason, pre-programming isn’t always successful in the pharma industry.

Cleaning validation

We felt a need to improve this, and conducted a trial of our own. We explored options ourselves, conducted the experiment, found it effective and circulated it to our industry colleagues for trial at their own facilities. They replicated it to test its efficacy.

When it comes to choosing cleaning equipment, we take a lot of support from our service partners, follow updates for new solutions from the industry, as well as remain in touch with our FM counterparts from other pharma companies.

Initially, service providers used to procure cleaning machines; now, we have started buying our own. We are open to both options.

Digital initiatives

Over the last two years, we have focused on digitalisation. With limited resources, we developed in-house software applications for various services like issuance of taxis, data cards etc, canteen coupon requests, visitor management, tracking of buses and more. We have graduated from hard copies to soft copies, and an app-based approval process.

Subhash Baidhya – Plant Head, Mankind Pharma

Air quality testing can be both active and passive. Air sampling is used for active testing. In passive testing, microbiological methods are used to check the air system, as well as the air, for contamination. If growth of microorganisms is detected, contamination exists.

Many chemicals used in pest management can be harmful to human beings. We should look for measures to prevent pest entry instead. Pharma production units are integrated facilities where openings are few and controlled. There are only doors, which have air curtains and other barriers. Preventing accumulation of waste, and keeping open areas consistently clean, is another approach to keeping pests away.

Hazardous waste consists of process waste and packaging waste. The former has two types: bulk process waste is what remains in the container/vessel after the production of each batch is completed; finished process waste is usually less in volume.

ETPs should never be left unattended, nor should waste ever be stored in the ETP area. This can lead to a foul smell. Both hazardous and non-hazardous waste is collected, segregated and sent for disposal to authorised vendors.

As far as possible, we should use green cleaning chemicals for the removal of micro and non-micro dirt. Anything that will not harm the environment is good for us.

Our sustainability initiatives include working towards carbon neutrality, reducing groundwater consumption and recycling wastewater. We have an RO system installed in the effluent treatment plant; the recovered water is used in the cooling tower and boilers. We are also exploring solar power as a form of sustainable energy.

Anubhav Singh Thakur – Assistant Manager – Procurement, Torrent Pharma

We have three requirements of any housekeeping vendor: The entire manpower must come from the service provider; there should be no absenteeism, so that cleaning is not compromised; all cleaning SOPs must be strictly followed.

We have shiftwise cleaning for the three production shifts, covering the manufacturing area, production area and packing areas. Cleaning validation is mandatory; a service provider needs to match the standards set by us, for which measurement is necessary.

We have separate vendors for housekeeping, transport, security, horticulture, laundry and other services. The industry needs housekeeping contractors who are experts in pharma FM. We use machines for deep cleaning, and are exploring robotic cleaning options as well.

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