ABC Pharma awarded ISO 9001:2008

Quality of products and standards of service are the decisive and game changing factors in the highly competitive pharmaceutical market in Sri Lanka, stated Kanchana Ratwatte, Chairman of Sri Lanka Standards Institute (SLSI).

“Pharmaceutical companies need to adhere to professional and regulatory standards and that will, in return, translate into increase in revenues. The criticality of the pharmaceutical industry is extremely high and therefore it is important for pharmaceutical companies to focus more on meeting and maintaining standards,” Ratwatte further said.

He made these remarks at an event held at Renuka Hotel in Colombo, where the ISO 9001:2008 quality standard certification was ceremoniously presented to ABC Pharma Services Ltd., one of the first few pharmaceutical companies to attain this standard. The event was graced by senior officials of the Sri Lanka Standards Institute, representatives of ABC Pharma partner companies, representatives of leading hospitals and retail outlets, and members of the Sri Lanka Chamber of Pharmaceutical Industry (SLCPI).

He commended this initiative by ABC Pharma, a fully Sri Lankan company in the pharmaceutical industry, who had achieved the criteria that comply with ISO 9001:2008 standards. “I, as the Chairman of the SLSI, appreciate ABC’s efforts and firmly believe that they will adhere to the ISO standards in all their endeavours in the future. SLSI will also work hand-in-hand with ABC Pharma to ensure that they meet the standards constantly and consistently,” the Chairman stated.

ABC Pharma Services, a leading importer and distributor of a wide range of pharmaceutical, healthcare and biotechnology products, received the ISO 9001/2008 certificate from Sri Lanka Standards Institute, becoming the second Sri Lankan pharmaceutical company in Sri Lanka to win this prestigious quality certificate.

The certificate was presented to ABC Pharma Services after assessing and evaluating its internal operational procedures, facilities and the quality of services it provides to the Sri Lankan healthcare sector.

Adrian Basnayake, Managing Director of ABC Pharma said the ISO quality certificate is an important landmark in the company’s evolution and a testimony to the high standards of service which they adhere to.

“The ISO 9001:2008 certificate was presented to us after a comprehensive study on the various aspects of our business. Firstly, the SLSI ascertained whether we meet the set and regulatory standards as a pharmaceutical company. Then they monitored our standard operational procedures in the company’s processors. In any company, there are specialised people who handle specialised operational areas. “However, the objective of this standardisation is to reduce the reliance on the individual and place greater emphasis on the system. The overreliance on any one specialised person, can result in the operational variability should that individual be absent or leaves, resulting in the company’s inability to maintain consistent quality of service. When presenting the ISO certificate, the SLSI closely examined whether we can maintain the same standards, even in the absence of specialised individuals.” Basnayake explained.

ABC Pharma is a company, which has adhered to implementing and maintaining stringent quality standards, earning them the quality standard certification. Since drugs are essentially temperature sensitive items, it is important to control and regulate the temperature in areas where drugs are kept. As Basnayake says, it is the responsibility of the company to ensure that drugs are stored, transported and distributed within the optimum range of temperature as specified by the manufacturer or the regulator.  

“Pharmaceutical companies, if they are to adopt best standards, need to walk the extra mile to validate and monitor the temperature of cold rooms where drugs are stored. In our case, in addition to continuous recording, we take six temperature readings a day in six places inside our cold rooms. With that kind of ‘temperature mapping’, you get a clear idea about temperature and potential ‘hot spots’.

“Drugs are stored or re arranged in cold rooms as per this information. It is an item, which you need to handle with the utmost care. For instance, many are conscious of protecting biological drugs from high temperatures which can significantly reduce shelf life, however if they go below 0 Celsius, that is very detrimental to the efficacy as protein molecules in most biological drugs can disintegrate rendering it useless.

“Similarly you need to be extremely careful when distributing drugs and adopt necessary measures to maintain cold chain requirements during transport as well. When it comes to certain drugs, we use a special gel coolant and validated thermo-cool boxes to transports them until they reach the end user. We are responsible for the quality and storage standards,” said the Managing Director of ABC.

In addition to such technical requirements, basic office conditions such as efficiency, cleanliness and general working atmosphere have also been taken into consideration when presenting the ISO certification.

“As much as we celebrate this achievement, it is important for us to commit ourselves to meeting the ISO standards consistently. The certification is renewed once in every three years and the SLSI closely monitors the standards and quality of our services,” he said.

Adrian Basnayake stressed that the patient is the most important factor in the value chain of ABC Pharma Services, adding that all actions must be geared to meeting the patient’s needs efficiently and effectively.