Pharma Solutions Bangladesh Limited has a fully-incorporated quality management system to ensure a constant level of services and products, including both pharmaceuticals and medical devices and is committed to highest quality standards.
The Quality Management System PSBL designed, developed and implemented is a 3 tier based system. The tiers are
- Quality Manual
- Standard Operating Procedures (SOPs)
The QMS adopted by PSBL is compliant with the requirements of Good Storage and Distribution Practices (GSDP) of WHO, EU, PICS etc, requirements of ISO QMS (ISO 9001) and the distribution quality requirements of world renowned pharmaceutical companies.
Our process flows, warehouse designs, standard operating procedures and employee training modules are updated regularly to ensure that they are aligned with global best practices.
The Quality Policy that we established and we adhere to is, “We the employee of Pharma Solutions Bangladesh Limited, proudly pronounce our personal commitment to fully understand, meet and strive to exceed our Principals’ and Customers’ expectations through
– continuous improvement of our processes and
– by performing the correct tasks error free, on time, every time.”
As of its commitment to continuous improvement and compliance with the highest quality standard, Pharma Solutions Bangladesh Limited adopted GSDP requirement in 2012. Since then it is the first and only GSDP certified company in Bangladesh. In 2013 it became certified on ISO 9001:2008. In 2016 it updated its QMS to revised ISO standard “ISO 9001:2015” and thus became the first distribution company to upgrade its QMS to the revised standard.
PSBL ensures that products are received and stored correctly, and the products are thoroughly checked against their label requirements. We can handle a wide variety of controlled temperature ranges from below 30° C, below 25° C, 2° C and 8°C. A lot of the products require controlled storage and transportation conditions of 2° C and 8°C, and we ensure that such products are maintained within the narrow temperature range throughout the distribution chain.
PSBL has proper processes for temperature mapping/validation along with a standard validation plan. We do a regular mapping of all of our storage areas. All the delivery vans are also mapped at a regular interval.
To deliver the products to the customer at right quality and right temperature, we have a passive packaging system which is also validated at regular interval. Seasonal variation and worst case scenario are considered during this mapping/validation study. To improve its cold chain packing system PSBL runs a continuous trial throughout the year. At PSBL hot spot, cold spots are monitored continuously to ensure that our controlled storage systems work efficiently and effectively.
PSBL keeps accurate temperature records and we have procedures in place for their review and approval. We ensure that recording and monitoring devices are calibrated regularly to cover the operating range. At PSBL we calibrate the device at minimum three points and it is carried out on a yearly basis.
PSBL has procedures in place for prompt notification of any deviations or complaint to the responsible person. At PSBL we make sure that a deviation from the labelled storage conditions of a product for any duration of time, for example during storage or transportation are promptly and thoroughly investigated, acted on against the proper root cause to prevent recurrence.
We provide appropriate training for our staff members who are involved in the storage and distribution of medicinal products, including delivery drivers. PSBL ensures that each employee receives a general introduction to Good Distribution Practice and this is incorporated to the training that is relevant to their specific responsibilities.
We have procedure in place to ensure that all changes in PSBL happen in a controlled manner. Changes are processed through a standard format, reviewed by a review committee and approved by the QMS head. During review process proposed changes, justification, impact assessment, risk and benefit assessment are done exhaustively. All changes are recorded in central register and for changes having impact on quality, they are notified to client and their consent are taken prior to approval of the change.
Effectiveness of QMS in PSBL is assessed in three stages which are “self-inspection”, “Internal Quality Audit” and Third Party Audit. Self-inspection is done by the site twice in a year. Internal Quality Audit is done by QMA department at least once in a year and Third Party audit is basically the certification body’s audit which is done once in a year. Apart from that PSBL appreciates its principal to conduct audit to assess the compliance with their requirement. A regular management review meeting is an integral part of PS’s Quality Management System.