Singapore’s Health Sciences Authority (HSA) recently released new guidelines on the preparation of a Site Master File (SMF) for pharmaceutical Good Distribution Practice (GDP) certification. While the application for GDP certification is voluntary in Singapore, those companies that receive a certificate should regularly update their SMF when any distribution practices are changed. A SMF should contain information describing product storage, delivery procedures, and any other distribution operations carried out by the distribution site.
A SMF should include the following nine sections: (1) General Information, (2) Personnel, (3) Premises and Facilities, (4) Stock Handling and Stock Control, (5) Documentation, (6) Product Complaints and Recalls, (8) Self-Inspections, and (9) Contract Activities.
The General Information section should include practical data about the site, such as the location, contact information and number of employees. The applicant should also indicate whether the site has received approval from the home country health authority. In addition, the applicant must list all activities and operations carried out on the site, whether or not the activities are pharmaceutically-related. Under the Personnel section, job descriptions of the key employees should be included, as well as an explanation of any in-service training programs provided to the workers. When appropriate, images, drawings or layouts should be included, such as in the Premises and Facilities section. The SMF should contain approximately 25-30 pages of information in total, and may be submitted to the HSA in hardcopy or electronic format.