How do you maintain quality throughout the supply chain?

I agree but there is one industry not mentioned that needs the exact same philosophy - the entire food industry including manufacturing, retail and foodservice.

Lol.. true but arduous to sequester these documents from your suppliers... customers want more than suppliers can offer typically. Gotta be on your A-game everyday!

Defining quality requirements for products and processes is indeed a critical step in maintaining quality throughout the supply chain. However, it is easier said than done due to several challenges. Firstly, identifying the CQAs and CPPs requires a deep understanding of the product, manufacturing processes, and potential risks. Secondly, establishing specifications and standards for raw materials, intermediates, and finished products requires comprehensive testing, validation, and data analysis. Moreover, the supply chain itself is often multi-tiered and global, involving multiple suppliers, vendors, and contractors. Each link in the chain may have its own QMS and procedures, making it difficult to ensure consistency.

Also need to define storage and shipping -requirements and specifications, which include environmental and packaging. This is for raw materials WIP and finished goods.

Quality is the business’ license to operate … if you do not have quality you have no license … So you have no operations …. No business … no jobs… no patient product …

This is super critical in manufacturing industry. What you put in is definitely what you'll get out. You cannot procure material of low quality and expect to produce a high quality product. Definitely don't just look at the licenses, certifications as a means of verification...go the extra mile, call the licensing authority or do an online search where that is available.

Also their credit worthiness. As this will give you an idea if they will try to cut costs and or go out of business and are able to pay there suppliers on time.

The first, and quickest option is to review your Approved Supplier List for an existing supplier that can meet your requirements. Providing they are qualified for the supply of a similar product, the process of selection and qualification is relatively quick. For qualifying a new supplier, you should schedule in an extended lead time into any project plan. To correctly qualify a supplier, you will need to implement a Quality Agreement, Technical Agreement, investigate and verify their certifications, assess their suitability for supply. Depending on the criticality of the supply chain, you should also consider an audit of their QMS.

Develop a program to audit suppliers to ensure that they meet the required quality standards. This can be achieved through incoming inspections, third party inspection services as well as site visits.

Agreed, quality is important at all stages, not just at the beginning when the contract/agreement is signed. Having several years conducting regulatory compliance inspections you'd be surprised to see the difference a day, week or month makes in a facility.

In my experience there is also need to involve QRM principles (ICH Q9). Although there is a case for phase appropriate GMP requirements; having commercialization as end goal is beneficial. Therefore, requiring raw materials to have CQAs aligned with commercial product in preclinical raw material specifications, will likely reduce the likelihood to make raw material specification adjustments or justifications at Clinical Phase 2 or later stages.

Also. Sop (stand operating pressures) and WIs (work instructions)need putting in place. So if there is a quality deviation anywhere it can be pin pointed and identify what went wrong.

Ongoing monitoring is just as important as the initial qualification. Once the task of qualification is complete, occasionally standards can slip without adequate oversight. Ensure that monitoring is appropriate based on the risk posed to your product and end user. AQL tables are great tools for monitoring incoming batches based on statistical sampling that gives you defined levels of confidence in your supply. During inspection, make sure you account for variable (continuous) and discrete (pass/fail) data in your sampling plans. You require significantly more data to ensure high confidence in your QC when reviewing discrete data when compared to variable data.

Timeliness and open communication with both positive and unfavorable feedback through the supply chain is critical to minimize disruption from deviations.

Conducting a risk analysis for the procurement needs can also help here. What are the negative risks (threats) that can happen? What do we do in case of occurrence. Who is our back up supplier? Is our minimum stock quota adequate for coverage should there be a shortage or late delivery?

This is essential. There is one caveat this needs to be made simple not complicated. The tendency to over complicate Change control which will result in people/suppliers finding a way to circumvent this.

The importance of working cross functionally with Design Assurance is critical regarding changes. Design Assurance will verify the risks have been mitigated, documented, and that the change qualification is robust from incoming inspection through real time self life testing. All cross functional work is important during changes to a device or product, but I feel it is critical to work closely with Design Assurance for supplier changes.

We also need to define accountability. Also install a no blame culture from top to bottom. Remembering it is the predefined stands that have failed not the person.

I have enough evidence that training of people involved in the food chain helps alot in maintining product quality. Another aspect is letting the personnel to have a sense of ownership and as such quality will be for everyone.

A Gap Analysis can be a useful tool to identify any existing differences between what is expected and what is occurring in reality. You can then perform a Risk Assessment of the gaps to prioritize any quality risks that must be mediated. A gap remediation plan can then be generated to execute and implement the corrective actions and improvements.

The first thing is to ensure manufacturing of batch with first time right and no deviations. The batch to be stored as per the required environmental controls at each stage and to be transported through validated route. A well established stability program will give early signals in any abnormalities in product. Last but not the least the product to be stored and used by customer as per product information leaflet.

Once a drug product leaves our physical "custody", the examination of our operational processes sometimes end there. It is still our responsibility to ensure the product is within specifications/compliance throughout it's life cycle until it gets to the patient. In one major CAPA I've owned, we clearly did not understand the process and operations that occurred once the product was transferred to other sites for continued processing (i.e. final fill/formulation and packaging). Per the CAPA, it was imperative to understand what happened when the product left our site. Process Mapping the product after it left our "jurisdiction" was a valuable tool in determining the root cause of the CAPA, and what needed to be corrected.

GMP Training. Adequate/Robust training programs for all personnel involved, (internal& external) goes with the accountability piece-to help ensure reproducible results of process & also effectiveness checks for training AND routine monitoring of Supplier performance.

Maintaining the quality of products throughout the supply chain involves various steps. It start by sourcing high-quality ingredients, conducting rigorous quality checks during production, and ensuring proper storage and transportation conditions. Regular inspections, monitoring temperature and humidity, and implementing traceability systems help us identify and address any potential issues. Collaboration with suppliers, clear communication, and continuous training of staff also play a crucial role in upholding the quality standards of our products from farm to table.