Why is foreign material control important?

Why is foreign material control important?

Foreign material control is critical for the US food industry. American consumers are very wary when it comes to food contamination, given their predisposition to diseases such as cancer. US authorities try to contain contamination in consumers’ food for a number of reasons.Foreign material control is important because:

–        foreign object contamination can create a bad experience for the consumer;

–        foreign object contamination can ruin a brand’s reputation;

–        lack of foreign material control can cause damage to equipment;

–        absence of foreign material control can lead to insurance claims and expensive legal cases;

–        foreign object contamination can cause direct health issues to consumers, ranging from broken teeth to laceration.

What can be done to achieve foreign material control?

US authorities have put a tool in place to bring about foreign material control. It is the Hazard Analysis And Critical Control Points (HACCP). The US FDA defines HACCP as “…a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.”

There are different HACCP systems in place for different types of food products:

–        Dairy Grade A Voluntary HACCP

–        Juice HACCP

–        Retail and Food Service HACCP

–        Seafood HACCP

Initial hazard analysis and the prerequisite programs are the most important aspects of the HACCP. Ahighlight of the HACCP is that limits, monitoring, verification and records in the HACCP program will not control unanticipated hazards.

Reference:

http://www.fda.gov/food/foodsafety/hazardanalysiscriticalcontrolpointshaccp/default.htm

 

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Why is a supplier audit program necessary?

Why is a supplier audit program necessary?

A supplier audit program is a must-have in medical devices and pharmaceutical manufacturers, especially those that outsource their processes. Being such an important element in the supply chain; a supplier audit program is the driving force towards ensuring quality and consistency in the supply chain, and is a very important component of the quality.

Expect to carry out a supplier audit program for these reasons

That a supplier audit program is certainly required is a given. If you are a manufacturer, why do you need a supplier audit program and what should you look out for? It is the manufacturer who has to undertake a supplier audit program because the FDA has NO regulatory requirement for a supplier audit. So, it is up to the manufacturer to ensure that he carries out a supplier audit program himself.

A supplier audit program could become necessary for these reasons or situations:

Initial: Things to consider could include whether you should pay a visit to the supplier at the start of the contract. Or do you make visits at regular intervals? How much time to you spend at the supplier’s facility?

Instances of noncompliance: At some point of time, you could come across a supplier who has failed to deliver to requirements. When say, the first shipment is not up to requirements, how do you tackle the issue?

History: It is possible that the supplier has consistently delivered negative results. If you have had a bad history of working with a supplier, what do you do? How do you haul him up? How do you correct the issue?

Criticality of the product or service: This could be another reason for which the manufacturer will need to carry out a supplier audit program.

 

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What are Design History File Requirements?

What are Design History File Requirements?

The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into the medical device manufacture worked in a preset process to arrive at the final product.

DHF requirements are an important component of the DHF. The DHF, a strict requirement from the FDA, is essentially meant to show conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is there to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. In other words, it eventually proves design control elements.

The US FDA states that DHF requirements need to be met. What are these requirements? The purpose of having specified DHF requirements is to ensure that user needs are met. It lists out a series of parameters that need to be met in order to ensure that these DHF requirements were met. These are:

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning
  • Design input
  • Design output
  • Design changes
  • Design review(s)
  • Design verification/validation
  • Design transfer
  • Design history file

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Supplier audit program

Supplier audit program

An internal audit program is needed for any business in which continuous work is needed, such as documentations. An audit ensures that the root cause of documentation is addressed. Documentation that is proper and process-oriented is a regulatory requirement, and hence an audit program is a must. A proper audit program that has tied loose ends up is a guarantee against any check from an external source, such as the FDA or an internal one, such as by the management or the firm’s partners.

The need for a supplier audit program

Why is a supplier audit program needed? In these days of globalization, most organizations, including medical devices and pharmaceuticals, outsource many of their operations. Products are manufactured in different locales, both locally and globally, before they are eventually consumed. A supplier audit program that is methodical, process oriented, transparent and scientific is the way to ensure that everything that goes into the manufacture and supply of these products is in line with set procedures and practices.

The criticality of the supply chain

The importance of and need for a supplier audit program needs to be understood in the context of an age where the geographical borders have blurred for global businesses. The supply chain, being the gel that holds the global business together, is stretched to different and diverse geographies. This is where the supplier audit program’s importance matters. A supplier audit program that is streamlined, visible and accountable is the best means to ensuring that the supply chain is robust and well-coordinated. This ensures smooth passage of the ingredients that to into the product, leading to hassle-free production, and eventually, profitable business.

 

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QBD in Analytical Method Development

QBD in Analytical Method Development

QBD stands for Quality by Design. ICH Q8 (R), Step 2 defines QBD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. QBD in analytical method development is an important component, as we will see later.

QBD in analytical method development

QBD in analytical method development means that analytical methods are the most important means to QBD, since the results are always scientific. Analytical methods provide information about process understanding, process control and product quality. QBD in analytical method development is useful for the following reasons:

  • Gaining prior knowledge needed for initial risk assessment
  • Assessment of material quality
  • Performing in-process testing for timely process control decision, which helps adjust processes before failures start taking effect
  • Confirms product quality, since it is understood that product specification quality is not the sole determinant of quality
  • It provides data to help understand the process better and bring about continual improvement
  • It confirms success of process change through routine and non-routine analysis.

The flow

This is how QBD in analytical method development can be shown:

Target measurement=>Selection of technique=>Risk assessment=>Method development=>Control strategy=>Continual improvement

Reference:

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM301056.pdf

 

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List of DHF requirements

List of DHF requirements

Which are the DHF requirements that the FDA looks for?

DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001.

It is meant to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. DHF requirements prove the efficacy and effectiveness of design control elements.

Details

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning –should relate the design and development plan –could ideally have Gantt Charts, reflecting changes whenever they are made
  • Design input –could explain requirements, Initial Product Performance specifications (marketing and engineering), and could include applicable standards, such as ISO or whichever
  • Design output: should consist of systems to evaluate design input requirements and should cover verification/inspection; QC and ensure proper functioning
  • Design changes –the FDA recognizes that any kind of change runs the risk of degrading the product; hence, the manufacturer should be on the lookout for possible snags
  • Design review(s), including by an independent reviewer, one who does not have a stake in the review process, should be prior to production. Should serve as milestones to take the product to the next level
  • Design verification/validation –the same as testing or inspection. It is basically meant to demonstrate that design output was a product of design input
  • Design transfer –involves transferring the R and D documents to design documents
  • Design history file, a complete documentation to demonstrate all of the above. This is the end result of all your design activities, proving that you got the process right.

 

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ISO 14001 internal audit

ISO 14001 internal audit

ISO 14001 is an Environmental Management System (EMS) that relates to the external environment in an organization. This regulation lays out standards and rules for implementation of external components of an organization relating to the environment. Based on Deming’s management cycle and modeled after the British standard BS 7750; ISO 14001 is related to other ISO 14000 standards.

ISO 14001 internal audit features

  • o   All its 17 clauses are standard requirements
  • o   Certification is valid for three years from the date of completion of audit
  • o   Surveillance audit is carried out every year thereafter
  • o   All types of organizations come under its scope, i.e. all kinds of organizations can be audited
  • o   It is integrable with ISO 18001, which deals with the internal environment policy of an organization, and ISO 9001
  • o   Certification is to be done by an accredited, registered body

Important points during ISO 14001 internal audit

The following points are important to note for an ISO 14001 internal audit:

  • o   Compliance with legislation
  • o   Organization-wide implementation of relevant sections
  • o   Demonstration of positive results
  • o   Demonstrate indicators such as water quality, emission levels, pollutants, effluents, etc.
  • o   Organizations should enlist their own indicators and show improvement from time to time.
  • o   Documentation
  • o   Preparedness for emergencies at the workplace
  • o   Preventive and corrective actions
  • o   Management review of all of the above

Audit methods during ISO 14001 internal audit

  • o   Plant tour
  • o   Observation and evaluation of compliance or deviation
  • o   Interviews with concerned staff
  • o   Documentation of records
  • o   Questionnaires

Reference:

https://docs.google.com/viewer?a=v&q=cache:ZGlN11iitNUJ:www.balticuniv.uu.se/index.php/component/docman/doc_download/653-auditing-iso-14001+Iso+14001+Internal+Audit&hl=en&gl=in&pid=bl&srcid=ADGEESjchpB8mRbpCf1ul-qB8v0YdqXgnJjmodDWBQ2nTzGksD0emgsCPL4CFaCgQk1mUFDGnx9yvtwSNsjRa9nq_OCZyL3oaaYp1bmaP-Qg1E_xkR3ZraahCgDhj-P1vhphjV67524F&sig=AHIEtbTFJMoezyNchaE9Jh-0bUC4S1H2vQ

 

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