Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
Validation impacts every process and component of pharmaceutical production, including machines, systems, equipment and computer systems. A large part of the validation and compliance process is in the documentation – there needs to be integrated support for documentation with complete clarity and traceability.
In today’s supply chain, the printer is arguably the final element in the validation process and with regulatory complexity increasing, not to mention industry-wide movement towards last-minute production processes, organisations cannot afford to omit this final stage of compliance.
However, the unfortunate reality is that many organisations do not realise their printer validation packs are incomplete and therefore not meeting US Food and Drug Administration (FDA) regulatory requirements. With the considerable risk and implications of non-compliance, Bart Vansteenkiste outlines how pharmaceutical companies can ensure their User Requirement Specification (URS) covers the final element of the production process.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
Good manufacturing practice (GMP) validation is an essential element of quality assurance underpinning the safety of pharmaceutical and biotech products and processes as set out, initially, by the FDA and now widely adopted by regulatory bodies globally such as the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Increasingly, other international regulators have followed suit, including Australia’s Therapeutic Goods Administration (TGA) and India’s Schedule M, with new regulatory requirements around pharmaceutical serialisation due to come into force in Russia, Brazil, Indonesia and China within the next two years that will further impact the pharmaceutical supply chain.
The risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation, to the temporary forced shutdown of a full production line and cost of remediating the situation, not having validated systems and processes in place could have a potentially catastrophic impact on any business.
Every pharmaceutical manufacturer will be aware of the requirement for GMP validated products and processes, whereby the company must demonstrate in a documented form that the processes, methods, tests, activities and equipment they utilise are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing procedure must be validated to perform as intended under defined conditions.
The documentation associated with validation includes:
Standard operating procedures (SOPs)
Specifications
Validation master plan (VMP)
Qualification protocols and reports
Validation protocols and reports.
Critical components
Labelling and label printing are critical final components of the validation process. In 2018, nine percent of all medical device recall events – and the return of over a million units – were due to labelling issues, with printing errors undoubtedly a factor. It only takes one stray label, instructions for use (IFU) or printing error to cause a product recall. A trivial issue like a faulty print ribbon, for example, can lead to missing, unreadable or misinterpreted content. When this goes undetected and products reach the supply chain, regulations are breached and patient safety is put at risk. Moreover, with an increasing shift towards just-in-time production processes, organisations need to ensure they have robust mechanisms in place to assure batch integrity. Of concern, most organisations are unlikely to realise that their printing systems do not comply, until regulators come knocking.
Good manufacturing practice (GMP) validation is an essential element of quality assurance”
The most reliable suppliers will be proactive in ensuring system validation, checking that what is required in the URS is delivered without error; providing a risk assessment; test strategy; good document standards and training protocols. A dedicated, good automated manufacturing practice (GAMP) V trained expert will know exactly what is needed to achieve validation in a pharmaceutical production environment, including validating any additional systems’ integration – such as a labelling or enterprise resource planning (ERP) system – and will provide the validation pack to support that.
It is ever more important that a company’s printing systems’ rationale can stand up to the scrutiny of an audit. So why leave the compliance of the final component of the validation processes to chance?
About the author
Bart Vansteenkiste is the Life Science Sector Manager of Domino Printing Sciences. With an engineering background, Bart has over 18 years of experience in advising manufacturers on how to best meet their coding requirements.
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.