Product Quality Surveillance for therapeutic products

Overview

The Product Quality Surveillance (PQS) Programme is conducted by HSA to monitor the quality of health products available in the local market. The programme aims to detect unwholesome, adulterated or substandard products and take prompt and appropriate regulatory actions to address any potential risks.

Regulation 65 of the Health Products (Therapeutic Products) Regulations provides the provision for HSA to conduct product quality surveillance for the purpose of ensuring that a therapeutic product is not a non-compliant health product ^[1].

Under the PQS programme, therapeutic products which are marketed locally are selected for routine quality testing based on a risk-based approach. Selection criteria for products intended for such routine testing is reviewed regularly and may include the product’s intended use, testing history and/or sales volume.

PQS may also be triggered based on information / alerts received or published and which have been assessed to have the potential to affect a therapeutic product’s safety, quality and/or quality negatively.

How are Product Quality Surveillance samples obtained?

HSA obtains samples of identified therapeutic products from dealers at all points of the supply chain including from product registrants, wholesalers and retailers.

HSA officers will contact companies or product registrants to schedule an appointment to obtain samples of the identified products for PQS testing.

Companies may also be requested to provide further information, e.g., product availability, marketing information, stock balance, to facilitate the PQS operations.

Companies/registrants will only be subsequently contacted if (i) clarifications are required; or (ii) non-compliances are detected.

What tests are conducted?

PQS samples are analysed at HSA’s Pharmaceutical Laboratory or other accredited laboratories to verify its compliance to registered specifications and/or quality standards as provided by the pharmacopoeias.

Depending on the reason(s) for testing, different tests may be conducted. Therapeutic products are typically assessed for one or more of the following parameters (non-exhaustive):

• Identity – identification of the drug substance(s) contained in the product

• Assay – determination of the potency / content of the drug substance(s) contained in the product

• Disintegration / dissolution – time taken for dosage unit to disintegrate / released and dissolved

• Microbiological tests – determining the level of microbial contamination, where relevant

• Sterility – determining if product is sterile as required under the registered specifications / quality standards

What happens if a therapeutic product is tested to be non-compliant?

HSA will inform companies/registrants if any non-compliances are detected. Depending on the investigations, HSA may instruct companies to take actions such as suspending sales and recalling distributed products. In addition, HSA may also commence investigations on companies dealing with non-compliant products.  

When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can be initiated to remove products with quality defects detected that does not impact safety or efficacy from the market to ensure that the therapeutic products available locally continue to meet the stringent standards stipulated by HSA.

Information on product recalls arising from HSA’s Product Quality Surveillance testing are published on HSA’s website www.hsa.gov.sg

Where the non-compliance detected pose significant safety risks to consumers, HSA may also issue press releases to inform members of public who have purchased or are using these products to stop using them to prevent further harm.

Is the testing conducted by HSA an affirmation of a therapeutic product’s safety and quality?

Testing by HSA is not intended as certification of the product safety, quality or efficacy. Selected test types are conducted to monitor a product’s compliance to requirements and quality standards. The samples tested also may not be representative of other batches of the product. As such, the PQS activity shall not be misconstrued as an endorsement/approval of the product by the Authority. The use of HSA’s name and/or logo in the advertisements or promotions of the product is not allowed.

^[1] A health product is considered as being non-compliant if (i) it has been manufactured, imported or supplied in contravention of the Health Products Act; (ii) it is an adulterated health product, a counterfeit health product, a health product that has been tampered with or an unwholesome health product; or (iii) it does not comply with requirements that may be prescribed