Developing Country and Management System Implementation

In 2009, GlaxoSmithKline decided to centralise the approval of its suppliers. The suppliers provided API (active pharmaceutical ingredients), excipients, packaging materials and raw materials to the company’s 70 manufacturing facilities worldwide.

These manufacturing facilities, especially those located in third world countries, had developed their own method of auditing and approving the suppliers. However, these methods did not conform to the requirements set out by the global audit standards that the company needed to meet.

The global audit standards are the standards developed by GlaxoSmithKline’s corporate audit and compliance department in the UK. They are used for auditing a pharmaceutical company’s suppliers around the world. The standards define the requirements of good manufacturing practices (GMP) for the manufacture and supply of active pharmaceutical ingredients, intermediates, excipients, raw materials and packaging components.

The global audit standard has four levels. Level 1 is the least stringent and is applicable to packaging material – low risk items. For a medium risk item, level 2 is applicable. High risk Items like printed cartons with patient and regulatory information, excipients and raw materials come under the Level 3 category. The Level 4 category is the most stringent of all categories and covers the active pharmaceutical ingredients, parental preparations and similar high-risk items.

The global audit standards include ICH, which is an abbreviation for the International Council  on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner. The global audit standards also include the International Pharmaceutical Excipients Council’s (IPEC) guidelines, Good Manufacturing Practice (GMP), and Food Safety standards.

The problem

There were more than 150 suppliers that needed to conform to these standards. The most difficult part was addressing their mindset and limited understanding of the global standards. This lack of understanding was mainly due to the absence of exposure to international standards and language barriers.

The pharmaceutical’s procurement department influenced the suppliers to comply with the standards, and they were able to do so effectively because ultimately the procurement department oversees taking orders for supplies. The suppliers were also informed that their ability to conform to these standards would result in their approval and their name and details being included on the organisation’s list of global suppliers. This list is visible to over 70 procurement and quality managers. Being on this list allows suppliers to increase their chances of expanding their business.

Due to limited or no exposure to international standards and little understanding of the English language among the suppliers, the initial audit was a combination of auditing and training. This resulted in many suppliers either being unapproved or conditionally approved.

The use of local language by the regional audit groups in Asian and Arab countries helped the suppliers understand the difficult requirements of the standards. The auditors went one step further and invited the suppliers to the factories to explain Corrective Action Preventive Action (CAPA) requirements and complaint handling procedures. This helped to conditionally approve suppliers that had previously been unapproved. Though this method was successful in implementing some of the standards at the suppliers’ premises, it was too slow and taxing for the auditors because it involved auditing on-site, preparing CAPA plans, visits, training, and general support to auditee to prepare their CAPAs and respond to complaints. However, despite this, the method continued for four years.

The auditors involved in the successful but tedious task of implementing global audit standards were not aware that the multinational pharmaceutical company had noted their success and developed a regional supplier quality operations group.

The managers of this group took the tasks that were previously carried out by the auditors, starting from implementing quality processes at the audited supplier facility, helping them in CAPAs, validation, complaint handling and training on new global initiatives.

Now the suppliers in third world countries speak the language of global quality standards and have also developed key quality processes in their own language.

For auditors facing a similar predicament, consider taking the following advice:

1. Let the initial audit be a combination of auditing and training.

2. If there is a language barrier or difficulty in understanding the standard requirements, consider using a translator or a co-auditor who understands the language and culture.

3. Ask your organisation to set up a quality operation department for training and support for auditees.

4. Initially invite the auditee for training in the areas where there were deficiencies noted during the audit.