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Steps to get ready for an overseas on-site GMP inspection for pharmaceutical products in Singapore

Steps to get ready for an overseas on-site GMP inspection for pharmaceutical products in Singapore

With the Covid-19 outbreak, many countries have implemented travel restrictions which have delayed inspections and business trips. Although business has slowed down, it’s a good time for us to review and realign our market strategy to the current situation. If you are currently an overseas company having plans to get your manufacturing site to be Pharmaceutical Cooperation Inspection Scheme (PIC/S) certified, Singapore is one of the best choices due to its stable socio-political situation and it has one of the most structured, organized and clear guidelines to get you started. I will take this opportunity to share with you briefly the 5 steps.

  1. For manufacturers who have existing Site Master File(SMF) and Quality Management System Documentation (QMS), it is good to start to align them according to PIC/S guideline for the Site Master File and to look into preparing Quality System Dossier (QSD) according to local regulations. A Quality System Dossier comprises of SMF, related QMS Documentation which includes SOPs, records, diagrams, workflows etc of the pharmaceutical manufacturing operations to provide an overview of the manufacturing site and its quality system so as to facilitate assessment of the manufacturer’s audit readiness.
  2. Conduct an internal audit to ensure that process workflow , documents and records are maintained as per Standard Operating Procedures and in compliance with Quality Management System set forth by the company.
  3. File for a product registration via a local agent or distributor to trigger the GMP inspection. An audit date will only be assigned should the documentation passed the desktop audit by the regulators. Any critical deficiencies will disqualify the manufacturing site from getting audited .
  4. Once the manufacturer has passed the desktop audit, a date will be assigned for an on-site audit.
  5. During the on-site audit, a list of observations, non-conformities and good practices will be presented during the closing meeting . The manufacturer will need to provide their Corrective and Preventive Actions (CAPA) 30 days from the date of the audit.
  6. If the responses provided are satisfactory, GMP certificate will be issued to the manufacturer within 10 working days calculated from the close-out date.

TRC offer the service of writing a QSD dossier for you. If you are keen, please feel free to get in touch.

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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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