Training programme.

Test facilities implemented extensive internal training programmes and engaged a range of external specialists, encompassing a wide range of topics (Table 3). Training was regularly identified as a key factor with recommendations made for earlier and more detailed training:

“If I were to start that process now, I will start with training. I would wish that we could be given no money but training, be trained a lot and then we start.”

Laboratory supervisor

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Table 3. Cited examples of training included as part of the GLP project.

https://doi.org/10.1371/journal.pone.0259849.t003

Internally delivered training included general GLP workshops, procedure-specific training linked to Standard Operating Procedures (SOPs), and refresher training on topics including quality assurance and computer use. General GLP workshops, particularly those delivered on a regular basis, were well received by staff at all levels and contributed to a consistent and shared understanding of the GLP project:

“I find it very useful because [GLP Manager], actually, helped us to change their mind; because to move on with this facility, people need to change the mind. Previously, we were running our business as usual but now we have to change, to be serious, to work hard, and follow the procedures, the SOP for running, for planning different activities.”

Data Manager

Awareness of why the test facility was seeking GLP certification, and understanding the personal benefits of working in a GLP test facility (including: job security, attracting new studies, a more comfortable working environment), increased buy-in to the project and willingness to adopt new working practices:

“… we did some introduction, training and explaining to them the advantage of the GLP, so everybody was like committed to make sure that we are into it … That training initiative helped a lot. If it were not for that, because they might think that we’re just disturbing them to do something else.”

Study Director

Generalised GLP training with all members of staff also promoted engagement. For example, because facility drivers understood the GLP project, they took care to ensure samples were delivered in good time from field sites to central laboratories:

“…for example, sometimes you can think maybe the driver is not a part of GLP. Now we know even the driver is part of GLP. For example, we want to take the specimen from one place to another and if the driver he or she don’t know what is GLP, he come late and then you have your specimen and the time is still going. So, your specimen is not good. Now all of us we are all ready, even the drivers they know. The administration they know.”

Technician

However, sustaining the intensity of training was a challenge:

“It’s about two months we haven’t met. It was weekly.”

Human Resource Manager

Whilst generalised GLP training supported facility-wide buy in and support for the project, role-specific training was important in ensuring that staff understood their individual role in the context of GLP:

“What is required, a lot of information, but they were for different—Because we are different people. Because the information for Study Director, that a Study Director should make sure—You must do this, this, this. The person who’s doing the experiment must do this, this, this. The person who’s archiving the data—It was a whole package, but it gave us a general picture of—Every person knew what he’s supposed to do in this.”

Quality Assurance Manager

The most consistently cited challenge with internal training programmes was the amount of ongoing on-the-job training and supervision needed to support technicians to change how they conducted and documented procedures. In some cases, this included asking technicians to change habits of more than 10 years:

“One thing is that when you come with new things, it means that you have to change the habit of people, which is not easy because people have their way to do and you say no. I know that you are doing like this they want to improve what you are doing. It means that if they have already a form to maybe evaluate the maybe record temperature or they have a form for something else, you have to say to them no. The SOP, this is the way we have to do the form. Sometimes they have problem. Where they say ‘No. We used to use this form more than 10 years, why you are asking us that this is not okay?’ It takes time to explain.”

GLP Manager

Practical approaches to training, including regular practice, helped technicians develop new habits. As observed by a technician:

“The way he explains things. He will sometimes ask you like, ‘Why do you do this? Why do you cut the ends of the pipette?’ He was asking us, ‘Are you doing that just for routine, or there’s a reason for that?’ Then I will say, ‘According to the SOP, you have to make the hole bigger, so that the tube will not get stuck.’ He was giving us questions, quizzes, every day, until he was comfortable that we’re good”.

A combined practical training, SOP review, and formative assessment process used in some test facilities engaged technicians when changing procedures and documentation. This helped ease this difficult transition period while also streamlining the process of developing SOPs and documenting training and competency in techniques:

“The training was the beginning before we start each and everything, we were trained and then we work practically with [IVCC staff member]… we enjoyed it because we are not learning in theory, we both theory and practicals, so we read and do it practically.”

Technician

Externally delivered training included formal and informal support by IVCC on topics including GLP principles, SOP development and implementation, techniques, quality assurance and data management. This was delivered in person at the test facility, or remotely via teleconference and email:

“Some of the things that we were working with, we had a lot of communication with [IVCC staff], ‘We’re stuck here,’ telephone conference and things like that.”

Laboratory Supervisor

This was identified as beneficial for overcoming sticking-points and facilitated further inter-facility learning as IVCC staff acted as a central resource. The network of collaborating test facilities was particularly mobilised for inter-facility learning for data management and IT infrastructure, building on the experiences of KCMUCo-PAMVERC:

“No, actually, previous I was doing these things but I was I was not doing at the level that is required by GLP. I have already attended one training which was conducted in the KCMC, Moshi. That one has actually changed a lot of things in my mind about data management and documentation.”

Data Manager

Attending international training related to GLP principles and sustainability for GLP was made difficult due to visa issues. This was easier for travel within Africa:

“No, within the African continent it’s very easy, yes. It’s much easier even to go to Asia it’s much easier … but to go to UK that is a challenge.”

Facility Director

Although there were still incidents of visa problems travelling between West and East Africa:

“With that, I think last year, I prepared to go to Tanzania to do data management training and I had a problem for visa. I didn’t move there.”

Data Manager

Beyond training for new or existing staff, consultants were an effective means of bolstering a test facility’s capacity on a temporary basis, and consultants were used in particular for GLP project management, auditing, and quality assurance:

“[On a consultant] Previously, we did not know exactly how to put in place. He helps us to, let’s say, to coordinate everything together because we know the different activities that we need to do. We do not know how to plan, for example to collect our equipment to other equipment for the calibration. I do not know exactly. He helps us to connect our facility here, our equipment with other equipment for the calibration and so on.”

Human Resource Manager

Identifying and engaging appropriate external consultants and training providers could be a slow process, due to a lack of regional providers. IVCC was able to provide some training, and as a result of the partnership between the test facility and IVCC, it was possible to address this challenge more effectively. This was, nevertheless, linked to the low control factor “availability and accessibility of support and expertise”.

Project planning.

Effective project planning was a key factor in overcoming the delays and challenges faced by test facilities. Project plans were put under pressure by unexpected disruptions, including flooding and changes in senior management, for example:

“Yes, there were delays during the heavy rains… We sometimes have a lot of rains. The road is not very friendly during the heavy rains, the period. It was not possible for heavy trucks to bring there some materials for construction. That was major challenge.”

Laboratory Supervisor

At some test facilities, this limited the number of tests they were able to include in their application to SANAS for GLP certification.

Regular meetings to review progress, highlight successes (both individual and institutional) and discuss challenges as a group were beneficial across test facilities where they were implemented. For management staff, these helped track project progress and sustain momentum. For technical and auxiliary staff, these meetings were highly motivating because they recognised individual and group efforts and reinforced the collective, team effort required to achieve GLP:

“Changing old habits is not easy thing. To overcome that issue, monthly meetings that we undertook were useful, as during those meeting, that issue was discussed and the necessity of GLP certification was reminded with rigor and insistence.”

Laboratory Supervisor

At one test facility, where technicians did not always feel able to air their views through team meetings, a system of technician and laboratory supervisor meetings feeding into senior management via an intermediary GLP manager allowed issues to be discussed and solutions identified. Working groups addressing specific areas of the GLP project were effective both in ensuring progress on that area and promoting ownership of the progress:

“The challenge we were facing with those new infrastructures was the respect of the recommendations by the builders. For this reason, in addition to the administrative and technical supervision team usually established for that kind of building, we have established our own supervision team. The different teams were meeting weekly with the aim for our team to make sure that everything was being done according the recommendations and GLP requirements.”

Laboratory Supervisor

Examples of working groups included overall GLP project management, construction, health and safety, and training programmes. These working groups included representatives from all levels within the test facility.

“On my side, technical aspect of the GLP, we also have a team which is actually led by me, [GLP Manager], and two more people. We are five altogether. Even [technician] is in that team. We have also the person from the accounts section and also from the procurement unit is also involved. We are actually reviewing weekly trying to see how these projects are going on, what are the challenges? Is there a need of maybe arranging a meeting with the director or somebody else about, do we need to sit with the contractor to rectify? Although it was a weekly meeting, but it was like every day.”

Administrator

The order in which activities were addressed allowed test facilities to tackle some issues in parallel. In particular, while infrastructure development, construction and rehabilitation was the activity that was implemented first at all test facilities, and was viewed as being the most important thing to address early on, other activities could run alongside this, including: recruitment of key roles (particularly quality assurance and data management); procurement (particularly of hardware and software necessary for computerised data management systems); and development of documentation related to the wider institution systems such as procurement and human resources:

“When we have been doing this renovation, there is other activities which has been going on like preparation like organogram, ordering of some of the equipments, laboratory equipments. The preparation of staff on the training about the GLP.”

GLP Manager

The work required to prepare and implement documentation for GLP, such as developing and checking SOPs, was substantial at all test facilities. In many cases, test facilities were working from a baseline of very few SOPs. SOP development had to be undertaken alongside routine funded project work putting a substantial burden on technicians:

“… we need to write the SOP with our technician who have been using all the SOPs but the number of technicians in our institution is very small, so we are not available in developing SOPs.”

Study Director

Individuals in other roles also felt this strain on their time, with study directors having to dedicate significant amounts of time to SOP development to alleviate pressure on technicians:

“…developing SOPs is a massive, massive role. [Study Director] and I get almost no writing done apart from writing SOPs for years, at least a year and a bit.”

Study Director

In some test facilities, these pressures were eased by appointing additional staff, often funded by IVCC and is, therefore, linked to the low control factor “funding”.

Senior leadership support.

GLP project staff valued senior leaders who understood the purpose of GLP and recognised the future benefit to the test facility in terms of data quality, prestige, and the ability to attract new studies. Senior leadership understanding and support of the GLP project was essential for progress. For example, delays in signing off budgets were minimised, and therefore barriers to progress on construction, procurement, and recruitment were reduced. In one test facility a change in leadership facilitated a rapid acceleration in progress as the incoming director of the test facility had been previously engaged in the GLP project. In another, a senior manager’s attendance at a workshop on GLP sustainability resulted in increased engagement and support for the project:

“Even this boss that we have was not in such a passion in the beginning than he is now after the training which they were taken, I think, to Liverpool, something like that. It was a training on business-related issues.”

GLP Manager

Infrastructure development.

The rehabilitation of existing buildings, construction of new buildings, and installation of necessary utilities and equipment was extensive at all test facilities (Example infrastructure improvements, Box 1). This was typically the first group of activities to be undertaken. The construction works required varied across test facilities, necessitating bespoke plans developed between IVCC and the test facility leadership. Developing the physical infrastructure for GLP was bureaucratic, costly and time-consuming:

“We needed to build a new laboratory. It took a long time to raise the funds necessary for construction. Also, the space to build the laboratory was difficult to obtain. Several discussions with the administration and IVCC have made it possible to build a new laboratory.”

Laboratory Supervisor

At some test facilities, additional investment was required to install utilities and repair roads:

“… in [Field Study Site] there was no house, so he was obliged to go to great lengths and those lengths was very far from the town. That means you have to set up electricity, water, let’s say water sources. This also was a great challenge for us.”

GLP Manager

At four test facilities, issues of land ownership influenced progress on infrastructure rehabilitation and construction. If test facilities did not own the land on which they planned to build, this caused disruption to progress on the project, either because it required negotiation with the landowners, or because project costs were inflated as test facilities purchased the land needed:

“It took a little time for us to get the initial approval not from [Parent Institution] but from the board that we’ll be allowed to make any changes that direct any structure around. That took time to negotiate, but when it was finally agreed then I was free to construct a structure.”

Test Facility Manager

Cost saving measures included test facility staff taking on construction project management roles, led by a working group drawn from laboratory staff and administrators. This came at the cost of their own time but facilitated local sourcing of construction materials and laboratory fittings, reducing overall costs:

“I had to use my brain to see how best we can do it. The idea which came into my mind was that maybe we invite these local contractors, but we need to supervise them. This was a huge task. You invite a contractor and then you buy all the materials. What you want to do is to borrow his labour charges. You procure all the materials. This is an area also which was a bit tricky because you had to have someone going around shop after shop, the hardware shops”

GLP Manager

Test facilities were also able to use the investment by IVCC to secure match funding from government and other partners towards construction of facilities:

“I can say that actually even 50% of the whatever we have achieved from other sources apart from IVCC, but the initiator was the IVCC. It has opened our minds that we can do that. If that is why the other people chipped in like the government, the institutions. They committed indeed.”

Test Facility Manager

This was made easier as visible progress began to be made on the facility.

Test facilities in Tanzania had the opportunity to learn from KCMUCo-PAMVERC. This saved time that they might otherwise have been spent interpreting the GLP principles and applying them to the facilities they were developing:

“First of all, we had a road map. Our experimental huts were old, and they need to be renovated. We visited the other site to see how they have done it. We had a model to see exactly what we are supposed to- where are we supposed to go from where we are.”

GLP Manager

There was a clear appetite amongst West African test facilities to similarly learn from test facilities that were further along the path to GLP certification:

“For example, in [Collaborating Test Facility]. I think they’re GLP now, so as it’s not far we can organize a touring there to see how they manage their sites.”

Laboratory Supervisor

Staff structure.

The structure of staffing at test facilities influenced the extent to which test facilities could reliably staff GLP studies. In particular, the organisation of technicians and how these roles were filled required specific attention.

In one test facility, most of the work undertaken at the test facility was by external researchers and PhD students, with only a small number of full-time technical staff to support this work:

“I’m the only technician here doing my work, but in terms of GLP everything has become tough. No access to do things because I’m the only one, so we will need maybe more personnel, more technicians.”

Technician

This put an undue burden on these technicians throughout the GLP preparation process and meant that the permanent workforce would not be sufficient for the conduct of a fully GLP compliant study for industry. It also increased the training and supervision burden on the technicians to ensure that visiting researchers complied with GLP requirements (e.g. using personal protective equipment).

In the government run test facility, staff could be moved or given additional assignments at short notice:

“… in GLP, we need someone to stick at the working place. If you are in the ITF, you are in the ITF, you should stick there. But as a government employee, sometimes you’re needed to go somewhere for a certain activity. I think that is another challenge. This is different from non-governmental institutions.”

Laboratory Supervisor

As a result, all roles needed a deputy to minimise disruption to the GLP project. The additional staff were not funded by the government so, for all facilities, it was imperative to attract studies from industry to cover additional staff costs. Interviewees indicated that it was not unusual for individuals in senior scientific roles to work more than full-time in order to make progress on GLP certification:

“…we subsidise research by working more than 100% FTE [Full Time Equivalent] with the Test Facility Manager and one Study Director paid from projects outside of the unit.”

Test Facility Manager

Procurement.

Delays and long lead times, particularly for international procurement, meant that procurement of both one-off purchases and consumables for studies was a key factor in test facilities’ ability to make progress with GLP certification:

“Yes. Some products are not easy to find in our area. It’s not easy to find some laboratory product in [country] and then when you find it here, it’s very expensive. Then [GLP project manager] can say okay, I will take it in London, take it in London is quickly where we put it on the boat one month or two weeks for example, and then they call you to say–ah, the material is here. We don’t pay VAT because we are an international organisation, we don’t pay VAT in [country], and then ask for exoneration from the Ministry of Foreign Affairs, we ask them to send us an exoneration document that can take 1 to 10 days. That’s why the delay can be very long.”

Procurement Officer

These delays originated from both internal and external systems. Internally, excessively bureaucratic systems and slow action by procurement departments, as well as delays in sign-off on purchases by senior management, were the principle sources of delay. Most test facilities included the streamlining of internal procurement processes as part of their GLP project. Engagement of the procurement and accounts departments and institutional leadership in generalised GLP training improved support of these changes:

“…the good lab practice to us as an accountant, we’re a little bit far from the lab but we are part of them, we’re doing our part of finance which assists the good lab practice. If they need items on time, item from the store, yes, we’re trying to push them to push those lists on time.”

Accountant

Test facility independence determined how easily adjustments could be made to procurement processes, with particular challenges faced by institutions linked to government or wider networks of institutions:

“Yes, maybe I can take you to experience the way I work with these guys here. They can have a test in the lab inside, and sometimes, they fail to ask that this component or chemical, they won’t be enough for us to facilitate this test in the lab. When they find that the things are not enough while they’re inside the test, they come and ask us, ‘Can you go and buy it for us fast, maybe fast-fast?’ Here, we have the process because we need to fill the document that you need the items and we need to take that document to head of department. Then from the head of the department to the center director or PI, we call it PI. Then from the PI to accounts department. Then from accounts department to cashier.”

Accountant

Shipping times and delays to delivery when goods were held by customs were also factors that influenced progress. Local rather than international procurement was prioritised at many test facilities, reducing lead times, but risking lower or more variable quality products. Procurement of key international purchases related to computer systems, such as servers, were an early priority at test facilities.

Expertise and support.

GLP-specific expertise often had to be sourced from outside the test facility, through recruitment, use of consultants or training of existing staff. The local or regional availability of appropriate providers of this training varied between test facilities, with some test facilities facing delays to progress while trying to source an appropriate provider, especially for general GLP training, and training for quality assurance and data management roles.

Data management support was made possible as the IVCC GLP project team developed their own expertise in data management for GLP as the project progressed, through a continuous learning process. This knowledge was then disseminated through the collaborating test facilities. Furthermore, all test facilities benefited from data management training for GLP from the data manager at KCMUCo-PAMVERC:

“Yes, for example, right after coming back from the training, from Moshi, there was one project that was going on. I started doing those small procedures in how to manage data and how to collect the data in a proper mechanism. Also, doing, for example, in that training also they insisted how to use the double-entry, which you are not doing, but now we are doing four projects doing the double entry.”

Data Manager

Calibration and maintenance of equipment was typically provided by a range of external providers, although finding providers who were accredited to do the work to the GLP requirements was a challenge, reflecting a lack of regional expertise and capacity:

“There are no accrediting body in [Country] which is a problem. In the maintenance of the equipment, the suppliers often don’t have the technology base.”

GLP Consultant

As well as calibration and maintenance of equipment, test facilities required support from government bodies that oversaw waste management and animal welfare. As with calibration and maintenance of equipment, these were services and support systems that test facilities needed but had very little control over.

Funding.

The implementation of the GLP project was costly with an average test facility budget of nearly $250,000. Additional costs to test facilities outside of the immediate GLP project increased the financial burden on test facilities. In particular, there were costs associated with meeting some GLP requirements in non-GLP studies, in order to maintain a GLP compliant environment:

“… on average that a GLP lab has a 30% increase in costs compared to a non-GLP lab. I think we pretty much have seen that over the past couple of years.”

Study Director

The costs associated with sustaining the GLP system beyond the period of investment by IVCC was a real concern for test facilities, with increased staff costs and increased overheads from running systems such as air conditioning units or generators:

“Although you might seek initial grants to establish the GLP, but sustaining it is a very big challenge. For example, you might be having a grant to enable you to have a power backup, which is a big problem in Africa to have reliable electricity. That generator, over the time, will require services and probably replacement later and that is costly. Sustaining cost is something to be expected. Not only what the initial cost is, but also you have to think about how are you going to sustain it.”

GLP Manager

Despite a good understanding of the business case for GLP and the need to attract studies from industry, test facilities generally felt they did not have the marketing skills necessary to sell their services on the open market, and identified this as a major risk to sustaining GLP certification:

“…it should be continued particularly on this marketing actually. Because now we’re going on marketing competitions. The GLP site should be trained on marketing. Marketing themselves with marketing their services, what they have, and also negotiation skills, and on contractual issues”

Test Facility Manager

Furthermore, test facilities were concerned that there was a disconnect between the sharing of best practice between test facilities and competing for studies as a means of ensuing sustained GLP certification, and that some test facilities had a competitive advantage through factors such as subsidised staff costs that meant they could offer studies for less than cost-price.

A degree of flexibility from IVCC on funding amounts, to pick up shortfalls in budget when unexpected costs arose, as well as match funding provided by, for example, the government or other institutions, was key for several test facilities. In particular, this ensured construction projects could be completed:

“This is the lesson what I’ve learned here because I know that we have got a lot—financial support from IVCC. Actually, that was not enough to achieve what we have now. I can say that actually even 50% of whatever we have achieved from other sources apart from IVCC, but the initiator was the IVCC. It has opened our minds that we can do that. If that is why the other people chipped in like the government, the institutions. They committed indeed.”

Test Facility Manager

This allowed test facilities to allocate dedicated time to working on the GLP project rather than in addition to full-time work on projects:

“I think for me first of all, IVCC did a lot of effort to extend the contract. That was for me the biggest support which helped us to make this big jump. Definitely, and that helps us now to recruit two people who were really key to help us to go.”

Director of Research

Test facilities which were not able to access this match funding found that progress was delayed as they were required to maintain a full schedule of studies throughout the process in order to cover core costs including institutional overheads, and therefore had less time to complete additional work needed to implement GLP:

“It had been difficult especially prioritising the GLP project while there is limited fund to sustain personnel employment and facility business. Therefore, we were balancing between GLP project activities and other projects that was meant to generate some funds to support GLP infrastructure/facility improvement.”

GLP Manager