Records - C.02.020, C.02.021, C.02.022, C.02.023 & C.02.024
Q.1 Must standard operating procedures (SOP) referenced in master production documents (MPD) be available at the importer’s premises?
A.1 Procedures related to critical processes must be available, whether or not they are referenced in the
MPD.
Q.2 Can chromatograms be stored on disc instead of retaining the hard copy?
A.2 Yes, refer to the Interpretation under Section C.02.020 to C.02.024 Records.
Q.3 Does the person in charge of quality control have to sign Quality Control (QC) data and documents?
A.3 QC data and documents must be signed by the person in charge of QC or by a designated alternate as per Interpretation 1.4 of Section C.02.006 Personnel, or Interpretation 2.2 in the case of a wholesaler. The person in charge remains accountable for the tasks delegated and retains the necessary authority.
Q.4 According to Section C.02.020 Records, documents to be kept by the fabricator, packager/labeller, distributor and importer must be stored on their premises in Canada. In the case of a distributor or importer particularly, these documents are sometimes kept only on the premises of a consultant hired
to provide Quality Control (QC) services, therefore they are not available on the premises of the distributor or importer at the time of the inspection. Is this practice acceptable?
A.4 No. All documents required under Division 2 of the Food and Drug Regulations must be available on the premises of the distributor or importer. Exceptionally, the consultant may bring a file home for a short time to review it but if at the time of the inspection, required documentation are not available on the premises of the distributor or importer, an observation to this effect will be made in the report. In some cases, this
could also lead to a non-compliant rating.
Q.5 If electronic signature is not validated, must the signed paper copy be available?
A.5 Yes. The signed paper copy should be available if the electronic signature system has not been validated.
Samples - C.02.025 & C.02.026
Q.1 What is considered an adequate sample when tank loads of a raw material is received?
A.1 As per Interpretation 3 under Section C.02.025-C.02.026 Samples, the retained sample should represent at least twice the amount necessary to complete all required tests. For bulk materials received in tankers, the retained sample should be taken before being mixed-up with the unused quantities still present in the storage tank.
Q.2 A pressurized tanker of hydrocarbon raw materials (isobutan, propane, etc.) is normally sampled and approved before pumping. What is the current Inspectorate policy for sample retention given the inherent risks generated by these flammable gases under pressure?
A.2 The intent of regulation C.02.030 is applied to these cases. Samples of pressurized raw materials are not expected to be retained by manufacturers.
Q.3 If a product is fabricated in Canada and exported outside of Canada (the product is not sold on the Canadian market), are samples of this finished product to be retained in Canada? (Updated)
A.3 No. This Canadian site is a contract fabricator and not a distributor. Subsection C.02.025 (1) of the Food and Drug Regulations (FDR) requires that a sample of each lot of the packaged/labelled drug be kept by the distributor and the importer (not the fabricator). This is also applicable if the Canadian fabricator manufactures a product for a Canadian distributor (Drug Identification Number (DIN) owner). While subsection C.02.025(2) of the FDR for retained samples of raw materials, the requirement applies to the fabricator (the person that transforms the raw material into a finished product), not the distributor.
Subsection C.02.025(2) of the FDR for retained samples of raw materials, applies to the fabricator (the person that transforms the raw material into a finished product), not the distributor.
Q.4 If a product is fabricated in Canada, and contract packaged by another company in Canada and then exported outside of Canada (the product is not sold on the Canadian market), who is responsible