The better you know your partner, the better the collaboration. Processing capacity, equipment conditions, cleaning and sanitation statuses, and protocols should all be part of the evaluation criteria. Touring a manufacturer’s warehouse and production rooms can quickly demonstrate the level of professionalism, organisation and operations of the company. Disorganised warehouses and production rooms covered in powder reflect a sense of mismanagement, Kokkinis says. At the end of the tour, brands should leave feeling confident that the manufacturer upholds the necessary standards of quality, safety and production abilities. A key point to keep in mind when profiling and choosing manufacturing partners is that they will be a partner for your whole company, de Jong says. The decision and project to employ contract manufacturing is sometimes decided by an isolated department’s need, but to bring a new product to market successfully, all stakeholders need to work together and understand each other—spanning R&D, engineering, operations, sales and marketing. Parameters and manufacturer possibility are best agreed directly on-site, Lopes says. A specialist in freeze-drying, Lopes enjoys taking customers into the -40°C plant, which demonstrate the temperatures at which the facility operates. Fortunately, we’re told all customers have survived the chilly tour.
Facility audits and red flags Once a manufacturer has been agreed and secured, audits will need to be taken at regular intervals to assess whether production and quality actions are being fulfilled, although these can also take place on a case-by-case basis. Although a manufacturer that is unwilling to conduct an audit is a probable red flag, ongoing COVID-19 restrictions and safety measures mean that some manufacturers have resorted to online and video audits. Brands may need to be aware of this reality depending on where production sites are based.
During audits, Guber shares that brands will want to ask questions around how incoming and outgoing foods are inspected, as well as ensuring external certifications are up to scratch.
For her British trading brand, Szymanowska enlists the expertise of a certified body such as SALSA (Safe and Local Supplier Approval) or BRC (British Retail Consortium), and the local council to conduct a detailed audit. She then investigates their findings before conducting her own audit.
During an audit, contract manufacturers are expected to provide all necessary documents that prove they are complying with cGMPs (current good manufacturing practices). This describes a set of requirements and procedures that, when followed, ensure that product goods are of high quality. There is a movement to improve quality standards in the industry, and these may vary from region to region as Pharmako’s Eric Meppem explains: “Australian GMP standards are based upon the PIC/s, international standards. Pharmako now applies these high standards to dietary supplements for bulk materials as well as finished goods. In the US, there is now the potential for amending Dietary Supplement Health and Education Act (DSHEA) to improve standards pertaining to original equipment manufacturer (OEM) and supplier GMPs.” Meppem believes these developments are essential for raising industry standards that bring long-lasting benefits to the industry and to consumers internationally.
Checking the level of license and certification that a manufacturer upholds, as well as who issued it. Brands will have a higher level of confidence if it has been issued by a government body such, as the FDA, TGA, MHRA, Health Canada.
Requesting details of the latest audit conducted at the manufacturer’s facility and reviewing the deficiency report as well as their responses to this.
Conduct a ‘paper audit’ (documents that detail financial statements, internal management, information systems and formal investigations)
Inspect the manufacturing facilities
Ensuring a Quality Agreement contract is reviewed and signed with the contract manufacturer
Audits are an essential tool to establish if the manufacturer shares the same ethos as your company. Quality varies amongst companies and regulatory imposed quality systems are only a starting point, a minimum standard, Kokkinis says, adding, “Tools in the quality system, such as change controls, deviations, corrective and preventative actions, annual product quality reviews, complaints handling, are very important for continuous improvement.”
Quality control and testing
Quality control and testing are not only necessary for meeting strict regulatory and compliance requirements, but must be conducted in the interest of product authenticity and consumer safety. Many brands differ in the stages at which they choose to test a product—often this is at ingredient level to confirm that raw materials contain the necessary contents and potencies expected.
Many product developers choose branded ingredients that are accompanied by research or clinical studies supporting health benefits and claims. “Some brands do not specify ingredient source, and this can be a lottery as there is a spectrum of ingredient quality on the market,” says Meppem. This relates to both the manufacturing standards and the testing standards.
Consumers are demanding more understanding about the ingredients contained in the finished products they buy, and it’s up to brands to provide them with the resources that clearly and transparently demonstrate that product make-up. “Consumption is no longer a passive act, but a deliberate one, in which consumers evaluate the impact of their purchase,” he highlights. “Consumers want to be stakeholders in consumption behaviour, and now often question the quality and origin of ingredients.”
Larger companies are more likely to have in-house expertise—with resources for laboratories and testing staff who can assess the quality of their ingredients. The majority of SME companies rely on external partners and, in fact, even larger companies are encouraged to enlist third-party testing. Who to recruit for quality control support will differ according to cost and assessment ability, but one should pay attention if no analytic results are provided at all, Guber says.
“Third party testing is essential and ultimately gives brands an added layer of security and confidence. It is not unusual to deal with multiple laboratories based on the testing required,” Kokkinis adds. For example, a single active ingredient assay, versus environmental contaminants, versus residual solvents are all lumped together under the ‘testing’ banner. Each of these requires very different equipment, expertise, and reference standards, which makes it almost impossible to have it all done in the one laboratory, he explains.
Emphasis has historically been placed on testing ingredients, and less so on the finished product. In addition to testing each batch of incoming ingredients for heavy metals, microbiology, identity, and active compound quantities, Klopčič says the same should go for testing finished products. “Not only is this increasingly demanded by pharmaceutical brands and certain stricter regulatory environments, but it is also a brand’s best bet for efficacious and safe products that will succeed in the market,” he says.
Not only do products need to be tested for ingredient content, but also taste, look, feel and smell may fall under additional testing criteria. They also need to get to market at the right time and the right price, and that dynamism may make it challenging for one company to have all the facilities, resources and expertise in house to develop, produce, test and package new innovations, says de Jong. Instead, there could be opportunities to use community models, such as using a co-packer for the packaging of the finished product. Using different contract manufacturing partners can offer flexibility in capacity or add expertise needed for the team.