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compliance

SUPPLY CHAIN MANAGEMENT

iCAN PURCHASING CONTROLS

Organizations must have a successful supply chain to compete in a global environment. An effective supply chain will deliver fast order turnaround, with a higher fill rate, with superior quality, while maintaining fewer inventories, at a lower cost. A strong supply chain will improve performance while reducing the breach between market needs and supply capability.

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The purpose of supply chain management is to integrate key processes to improve performance and reduce costs. This is accomplished by creating trust and collaboration between supply chain partners throughout the network. When suppliers can focus on their core competencies they can perform better and be more cost effective.

Do you have a new product or service idea but do not know where to begin?  Perhaps, you want to expand your operations overseas?
 
Well, you just stumbled upon supply chain management.  
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Supply chain management is the movement and storage of raw materials, of work-in-process inventory, and of finished goods from point of origin to point of consumption while also considering the product and service business, legal, quality, regulatory and operational laws, requirements, costs and change management considerations.
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However, when walking into the uncharted waters of supply chain management, please be aware of the following two (2) phrases:

 

  1. ‘Caveat emptor’ … buyers beware; and

  2. Illic 'potator natus perparvis … there’s a sucker born every minute!

 

Well, do not fret…. the experts at iCAN GMPs are able to save the day.  Not only are we equipped to assist with the setup of your new company, but also help your company grow internationally into a flourishing effective and prosperous multinational company.

 

Did you know that there are three (3) types of suppliers?

 

  1. Vendors- companies in which you obtain raw materials;

    1. Internal vendors- vendors that are part of your organization but may operate under separate quality management systems (i.e. ‘sister’ companies)

    2. External vendors- vendors that are not part of your organization and operate under their individual quality management systems

  2. Contractors- outsourcing companies in which provide necessary services for your company; and

    1. Contract sterilizers- companies that sterilize your products under contract

    2. Contract manufacturers- companies that perform various manufacturing operations under contract, such as:

      1. Production and operations activities, including:

        1. Process management

        2. Planning and logistics

        3. Re-packaging and re-labelering

        4. Designing

        5. Warehousing and distribution

        6. Overwrapping

        7. Translation services

      2. Quality, regulatory, and compliance activities, including:

        1. Management requirements, such as:

          1. Quality planning

          2. Quality procedures

          3. Management reviews

        2. CAPA system operations, such as:

          1. Product and process nonconformances

          2. Corrections, corrective actions, and preventive actions

          3. Complaints and adverse events

          4. Recalls, corrections, and removals

        3. Calibration and metrology

        4. Validation and verification

        5. Internal and supplier audits

        6. Change management

        7. Training

  3. Consultants- companies which guide and mentor you for success, with qualified subject matter experts performing various operations, including:

    1. External and mock audits

    2. Gap analyses

    3. Corrective action

    4. Remediation

    5. Certification and qualification

    6. Training

Also, did you know that there are other companies involved with fulfilling your operations beyond manufacturing?

 

  1. Warehouses- companies that store raw materials, in-process materials, and/or finished goods

  2. Distributors- agents that obtain, warehouse, and supply raw materials, in-process materials, and/or finished goods to retail stores and/or directly to end users and/or other customers

  3. Importers- agents that bring raw materials, in-process materials, and/or finished goods and/or services into a country for sale from another country

Did you know that poor supplier quality will have an impact on product performance?

 

Additionally, were you aware of the various business, legal, financial, quality, regulatory and operational laws, requirements, costs and change management considerations associated with supply chain management? 

For example:

 

  1. Business, legal, and financial issues pertaining to poor procurement, quality, delivery, and cross-functional cooperation and communication ;

  2. Implied supplier quality requirements for pharmaceuticals under FDA’s pharmaceutical cGMPs- 21 CFR parts 211.22 and 211.80;

  3. Voluntary supplier control requirements for pharmaceuticals under International Council on Harmonisation (ICH) Q9 Pharmaceutical Quality Risk Management and Q10 Pharmaceutical Quality System;

  4. Mandatory purchasing control requirements for medical devices and combination product with medical device constituents under FDA’s medical device quality system regulation- 21 CFR part 820.50; and

  5. Voluntary supplier control requirements for any deemed food, pharmaceutical, cosmetic, biologic, medical device, tobacco, and cannabis products under ISO 13485 sections 7.42, and 7.43.

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With iCAN GMP professionals’ assistance, you will never have to worry about the following supplier management issues again:

  • Supplier performance management

  • Supplier improvement programs (certified vendors)

  • Internal supplier qualification

  • Defining roles and responsibilities of supplier and manufacturer

  • Periodic supplier audits

  • Supplier capability development

  • Supplier collaboration

  • Supplier risk management

  • Incoming testing

 

For example, iCAN GMP experts will:

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  1. Assist you with set-up operations, including:

    1. Quality, regulatory, and compliance requirements

    2. Logistics, importing, and exporting requirements

    3. Production and operations requirements

    4. Risk and resource management

    5. Written procedure templates

    6. Supply chain operations, including:

      1. Supplier, manufacturer, distributor, and customer selection and assessment (including contract and quality negotiations and agreements)

      2. Supplier, manufacturer, distributor, and customer control and evaluation

      3. Translation of company product and process specifications into supplier, manufacturer, distributor, and customer requirements

      4. Working with outsourced supplier, manufacturer, distributor, and customer teams

  2. Supply you with approved vendors and contractors that have been certified though iCAN GMP quality audits

  3. Perform necessary internal, supplier, and external audits

  4. Develop processes and tools to for you to monitor various risk-based and statistically- justified supply chain management activities, including:

    1. On-time delivery

    2. Quality reject rate of incoming parts and components

    3. Supplier responsiveness to business and quality issues:

      1. Supplier corrective action report process

      2. Cycle time

    4. Number of supplier incidents:

      1. Recalls related to supplier parts and components

    5. Supplier-related issues impacting manufacturing:

      1. Shutdown related to lack of material or quality-related issues

    6. Supplier audit results

      1. Status of preventive

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