Toronto, ON-- Health Canada is proposing revisions to its Good Distribution Practices that will impact the pharmaceutical industry in Canada and supply chain partners.
Sarah Skuce, Compliance Specialist, with Health Canada, discussed the agency’s proposed revisions at this week's 11th annual Cold Chain and Temperature Summit Canada, running February 27 and 28 in Toronto.
Health Canada’s GUI 0069 Version 2, (Guidelines for Temperature Control of Drug Products during Storage and Transportation ), or “Guide 69” in industry parlance, is undergoing its third revision before being released for comment.
Skuce said she wants to extend the industry comment period if possible up to 90 days given that Guide 69 “seems to get a lot of attention. It’s inclusive of all drug products, all pharmaceuticals, veterinary and human. All regulated parties are covered in the guide. Transport providers are not covered but are expected to follow the guidelines,” she said.
Skuce noted there have been “great and monumental changes in the pharma industry” since it was first surveyed in 2003.
Guide 69 emerged from this survey to respond to the need for additional guidance on procedures.
“There has been a noticeable increase in knowledge now in the industry. But transportation providers are still reluctant to sign quality agreements, and this is not going unnoticed. It is still your responsibility to get these signed as shippers. If the 3PLs or transport providers will not sign, think of alternatives. If the quality agreement is not in place there need to be additional controls to transporting your products safely,” said Skuce.
The guidelines aim to ensure drug products in Canada are transported, handled and stored to mitigate any risk of exposure.
Drugs should be stored “according to the label requirements” as the minimum default.
Shipping containers, shipping procedures and packaging configurations should be qualified. Ideally, the guidelines will advise that labels should also be on the shipping containers, as well as on the actual boxes being shipped.
If there are special handling requirements, these should also be on the shipping container.
“There must always be quality control sign off for actions taken after an excursion,” noted Skuce.
The pharma industry should be aware that inspectors will follow products from the receiving end through the entire process.
“We’re also taking a look at shipments upon receipt. For controlled substances, we don’t really go into it other than here’s the area you should be looking for,” said Skuce.
But when it comes to records of inbound/outbound shipments, “if you do not record it or document it, it never happened,” she added.
What hasn’t changed in the revision is that written agreements between regulated parties and transportation companies are still required.
Guidelines on humidity and light controls remain in the text, but counterfeits will be addressed in another document.
What do inspectors expect?
On quality control sign-offs, the expectation is that standard operating procedures are “qualified, updated and modified.”
“Many people are dinged for not signing off on their SOPs. Be up and current with personnel and employees on training,” said Skuce.
She said Health Canada has tried to get more guidance from industry on quality agreements, but industry should expect that inspectors will be looking for lists of products that have storage or transportation requirements. They will want to see procedures on incoming goods, outgoing and returned goods.
“Contingency plans are a new requirement since last revision. We expect you to have contingency plan and considerations when at the border for feasible corrective actions and timelines, and considerations for supply interruptions of medically necessary products,” said Skuce.
While many pharma companies are proactive about alerting border officials and educating their carriers and drivers, at the end of the day, product integrity remains the responsibility of the company.
“The regulator is doing good manufacturing practice, the border is doing security-and this is something all of us in the pharma industry need to pay attention to,” said Rafik Bishara, Technical Adviser and Leader, PCCIG, PDA, and a conference moderator.
Inspectors are mindful that supply interruptions have implications
Common compliance issues are temperature monitoring and mapping, quality agreements and the training of personnel.
“We see a lot of procedures lacking, including improper temperature ranges for a selected device, no assurance of product quality as well,” said Skuce.
Among wholesalers and importers, transport and storage excursions are the most typical deviations. Sometimes this is as a result of creating benchmarks that can’t possibly be adhered to.
“Some companies will create their own stringent guidelines or SOPs and when it comes down to it they can’t sign off on all of them,” said Skuce.
There is a general requirement for the pre and post calibration of temperature monitoring devices used to map cold storage areas, applicable to thermocouples, but not necessarily to thermistors.
A Good Management Practices (GMP) bulletin will be going out to all inspectors regarding requirements, expectations, and exceptions, noted Skuce.
Other lessons learned? Manufacturers do not want to share their stability data with wholesalers and warehouse providers, she said.
“Some are developing their own data, but in the absence there always needs to be a plan B, as in, there shouldn’t be ‘excursions’ at all or, you must hold the shipments to the label requirements as a default practice.
In warehousing and wholesaling there have been lots of deficiencies in temperature mapping.
“We look at this quite heavily during the course of an inspection.You need to map your fridge empty and loaded. You need a separate power source for probes and alarms,” said Skuce.
When it comes to product returns, “Our default position is destruction. We will look very heavily at what your actions are after a return to a facility. If (a product shipment) never actually leaves your possession or control it can be released as resaleable stock. If you are asked for any verbal attestations, don’t do it, throw it out,” she said.
The next steps for the GUI 0069 version 2 guidelines will be a Q & A document for Health Canada’s website, and a guide on written agreements with transport companies.
“The Active Pharmaceutical Ingredients (API) regulations will be appearing in Canada Gazette No 2 in April 2013. They will be included in the scope of GUI-0069,” said Skuce, who invited comment from stakeholders for the final revisions.