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Developing And Executing A Program For Labeling ComplianceDocument Transcript
Developing and Executing a Program for
By: Chris Miller, Prisym ID
Labeling has become a complex process from its humble beginning as a method to keep track of
what a container had inside it. It usually shows not just the product name and its ingredients
but also information on how to safely use the product, people who can be held accountable by
the government (e.g. the manufacturer), and at times the names of the companies who
Research is also pushing the boundaries of science at an exponential rate. With new
discoveries come new products. These, more often than not, necessitates adjustment of
present legislature for the good of the common man. In September 2010 alone, the FDA
finalized two new Guidance Documents and is drafting an additional three1. This further
complicates an already complicated situation.
It becomes even more complex when products are exported to other countries. Each
government entity has a different idea concerning what should be printed on these labels and
the process of labeling. A good example is a move lately to make chemical labels uniform
across the globe. It is called Globally Harmonized System of Classification and Labeling of Chemicals
(GHS). The goal is to either decrease or eradicate entirely miscommunication regarding chemicals so
people and the environment could be better protected2. The long term prospects for this in decreasing
labeling complexity, at least between nations, is promising. Unfortunately, this means a lot of work
while the transition is being made.
Having a program for labeling compliance designed to adapt to such changes will help the company
successfully adjust to them. It will also lower financial losses from recalls or production delays because
of package labeling mismatch for instance.
Programs are developed. It starts with knowing who the key players are in the process, the products
involved and the scale of manufacturing and distribution, formulating a plan that encompasses this,
implementing and evaluating the whole process with an eye towards circumventing errors. This guide
will provide a company with the means to obtain a solution that would fit their particular labeling needs.
Table of Contents
Some complexities of the labeling process 3
Who are involved in the labeling process 4
Matching the challenges to the solution 5
Key traits of an ideal solution provider 6
The different approaches to developing a solution 7
Composite solution from several sources
Implementing the solution 8
User familiarity and access
Full lifecycle documentation
Integrated Packaging Management
PRISYM ID Solution Features 9
Some complexities of the labeling process
A new invention or medical device follows a long complex process prior to market approval. This
process is usually begun with a Pre-IDE submission and a determination meeting with the FDA. This is
then followed by an agreement meeting that will set the environment for clinical trials. An IDE is given
so clinical studies may proceed which will lead to pre-market approval then ultimately to market
Once market approval is given a package label is then conceptualized and sent to the requisite
government agencies for approval. Where the product is to be marketed is an important factor to be
considered. Manufacturing, packaging, and shipping is then set into motion.3
The definition of labeling today encompasses not just the label and the directions for use that go inside
the box. It includes advertising according to the Food Drug and Cosmetic act as interpreted by the
Senate and an appellate court decision. The FDA, as a rule for in vitro devices, requires promotional
claims to be approved by and cleared through them. They also set limits on what claims can be made.
Products are advertised long before they hit the market; labeling, thus, begins prior to label
This process becomes more complicated when there are changes in labeling requirements, especially if a
product is already in the market. For example, in November 2005 the FDA required a new electronic
structured product label for Prescription Drug Information which would allow users to look for certain
information. About three months later, new data was to be included in the Prescription Drug
Many of these changes were instigated to improve user safety. This goes into the package insert. The
package label, printed matter on the box itself, will contain information on the manufacturer, or the
manufacturers if there are several, aside from the usual brand name, product description, etc.
Who are involved in the labeling process
A company putting together a labeling program must include in its planning team people from, or who
liaise with these key areas: Manufacturing and Packaging, Information Technology, Marketing and
Advertising, Distribution, National and International Regulation, and Quality Control.
Manufacturing and packaging being the operational arm are places where mistakes can be spotted and
addressed before the products enter the market. A delay in production is preferable to product recall.
Once a good system is in place errors of this nature will rarely reach this part of the process.
Marketing and Advertising will make certain that the way a product is marketed and what goes into
each advertisement complies with labeling regulations. They also ensure that the brands appearance is
consistent with company standards wherever the product is marketed.
Distribution will monitor that whoever markets the product and wherever they are sold maintain
accuracy. Everyone in the chain of distribution from suppliers to the primary and secondary
manufacturers to the retailers at the end of the chain should be aligned with labeling and packaging
policies of the product manufacturer shouldering the brunt of the responsibility.
Information Technology’s role is essential in coordinating the data generated by business enterprise
software such as Enterprise Resource Planning and Customer Relations Management applications.
These tools help in administering the whole business operation and in managing interaction with
customers. IT can contribute significantly to product labeling and keeping track with how customers
view these labels and their response to the advertising campaigns.
Liaising with National and international regulatory bodies is paramount. These bodies impose rules on
the direction labeling and packaging take. The ability to adapt in a timely manner and contribute to the
formulation of such changes will save the company from losing profit.
Quality Control makes sure that the final labeling product does not have any defects and complies with
all prevailing regulations through every step in the process.
Matching the Challenges to the Solution
Each company faces a different set of challenges in developing a labeling program. Putting together a
team to identify these challenges these challenges is important. The main objective of the team will be
an assessment of the company’s present labeling practices compared to the current standards and
regulation, expected and projected changes in labeling regulations in present and anticipated market
distribution areas. An important initial step is searching out where this information is stored for access
and utilization is. Once this is gathered, a strategic plan for updating current practice can be formulated.
The risks involved may surface when there are exceptions in the process or procedures designed to work
around regulation instead of with regulation. Existing work flow and procedures when creating a label,
and number of products requiring labels or updated labeling should be analyzed carefully.
Documentation involved in process from the creation of a label or template, to its approval and filing in
an archive should be kept for future reference. This will help when looking for breakdowns or, better
still, for circumventing errors.
Optimizing the efficiency of the whole process of labeling and configuring it to fit your business system is
part of the role of Enterprise Resource Planning (ERP). The different parts of a business system (i.e.
materials management, human resources management, production management, manufacturing and
administrative management intelligence, billing, customer relationship management, and financial
management) produce different types of data that need integration. Those that bear directly on the
production of a label such as lot number, expiration dates, date of production (these are the more
obvious ones) should be identified. Those not readily evident are also important to take into account
like whether data from labeling software is reprocessed to fit an ERP, what initiates the process printing
of a label, and they way information is reconciled with each other (by batch or as they happen).6
Problem areas or points where errors surface should carefully documented and a methodology for this
established. This is a critical part in improving the process so in the future it runs ideally without
breakdown. Undesirable events like recalls due to labeling should be backtracked so it can be modified
at the point where the breakdown began. All information on this should be kept but easily retrievable.
These may be painful reminders of mistakes, yet they are important to the process.
Future needs should also be mapped out, as much as possible, so the plan produced will be
sufficiently flexible and easily adapted to meet them. It would not do to have a labeling
program in operation but discover later on that it cannot be modified or utilized for new
products or in coordination with new partners.
Key traits of an ideal solution provider
These are the traits to consider in an ideal solution provider, whether the solution comes from within
the company structure or from an outside source:
Any solution provided, be it from within the company or from an outside source, should be a
collaborative effort focused on user requirements. Each part of the different systems used in the
process should follow the principle of ease of use for the system’s user. Training modules are also
important so every person involved in the solution’s implementation has the requisite expertise.
A total labeling solution should be what the final product delivers. It should take into account every
aspect of the operation particularly those that have an impact on labeling. It would not do to have a
solution confined to just the designing and the printing of labels. Regulations, such as Title 21 CFR Part
11, Universal Device Identification, Good Manufacturing Practices, etc., should be integral to
solution itself. Furthermore, as regulations change with the times, solutions should likewise be
adaptable without too much modification or customization that might render it too complex for
People or companies who participate in providing the solution should have enough experience in the
particular whichever part of the solution they work on. Otherwise, pinpointing errors, areas of possible
breakdown, and predicting future development would be very difficult and potentially very expensive, if
not impossible. If an outsourced solution is required, a company with proven and demonstrable track
record would be the best choice. Entrusting your labeling solution to start-up companies might seem
like the cheaper option; however, their lack of experience might lead to expensive errors in terms of
profit lost due to recalls or fines.
Developing a solution
There are four ways a solution (and its accompanying software) can be developed.
A company may opt to develop its own in-house solution. This may look attractive on paper but, unless
the company is planning to heavily invest and enter the labeling solution business, not advisable. Once
the system is up and running, many key personnel and systems during its development either become
superfluous or are underutilized (very similar to buying a powerful computer but using it as a simple
word processor). Error correction will only be marginally faster than if the solution were outsourced.
This will not justify the investment.
Another option is to acquire some components from outside then integrate it into the existing system.
This might be ideal if the problem is confined to a small area of the labeling process and the existing
system has been analysed to already be a sound solution for the company.
Those whose strategic planning team for the labeling process conclude that the whole system needs
overhaul or built from the ground up should consider taking on one solution provider. The one they hire
should ideally have a proven track record. They may be more expensive that start up companies but the
experience they have in the field will more than compensate for the expense in the long term.
Taking the best components from different providers and combining them into one is another seemingly
attractive option. However, the process of making these different systems compatible is the significant
drawback of this solution. The company would be spending resources on something that would not
arise if a single outsource company were doing the work.
Implementing the solution
User familiarity and access should be commenced once an ideal solution formulated. There will
be several operational groups for work areas and different stages of the labeling process.
Training need not be implemented concurrently but each group must be trained sufficiently
prior to operation.
In some cases validation like IQ, OQ, PQ is necessary for some types of products, like medical
devices, so that current good manufacturing practices are satisfied. This will help in monitoring
the manufacture of the product meets the specifications. In the case of IQ, OQ, PQ, it should
cover everything from the qualification scope documented in a validation master plan to the
validation master report or other similar requisite reports. It should also form the basis for
ongoing change control and retrospective validation.7, 8
Label Design has to comply with label regulation like 21 CFR 610 which deals with what the
different labels should contain. Variable data inclusion should also be carefully considered
when allowing for customization so several product lines and new product lines can be covered.
Full lifecycle documentation is important as this is basically an information system being
developed. Errors in the system can then be traced and changes that need to be instigated
In order for management oversee the whole labeling process in several locations Integrated
Packaging Management is instituted. This is another important factor in circumventing possible
breakdowns of the system especially if implementation is distributed between several
operations units. Part of this is monitoring Supplier and Contract Manufacturer Compliance of
mandated regulations. The primary manufacturer bears the brunt of the responsibility when it
comes to proper labeling. 9
Another important factor in tracing errors or breakdowns in implementation is tracking
inventory, assets, and stocks. In the worst case, knowing where the products are in the event
of a recall will facilitate its execution. Ideally such mistakes should be circumvented prior to
PRISYM ID began in 1981 as MAP80 Systems Ltd. It obtained ISO 9001 and TickIt Accreditation
in 2000. The label PRISYM ID was launched in 2003. The following year, the senior executives
bought out the company and re-launched it as PRISYM ID Ltd.
PRISYM ID Solution Features
User Requirement Specification starts off the process and is integral to any solution provided.
This is developed in collaboration with the client’s labeling program strategic planning team and
PRISYM ID specialists.
All software provided is Purpose Designed and meets all the regulatory standards so only
minimal customization is required. This means that the time interval between planning the
program and implementing would be shorter than if extensive customization were needed.
This will make it easy for the client to take advantage of opportunities within a reasonably
period after they arise.
The different software offered can easily upgraded and customized so that changes, such as
new regulation requirements or new distribution points, can be met with little or no difficulty.
Aside from this, the software available addresses various necessary requirements from the
clinical trial stage of the product to be marketed, to its validation, and until packaging and
U.S. Food and Drugs Administration Newly Added Guidance Documents (2010 September 28).
Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
About GHS: Globally Harmonized System of Classification and Labeling of Chemicals. Retrieved from
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry
and for CDRH Staff (2009, November 20). Retrieved from http://www.fda.gov/MedicalDevices/
Novalles-Li, Philipp. Policies guiding the advertising and promotion of IVD products (2009 April)
Retrieved from http://www.ivdtechnology.com/article/policies-guiding-advertising-and-promotion-
The FDA Announces New Prescription Drug Information Format (2009 November 11) Retrieved from
Enterprise Resource Planning (2010 October 11). Retrieved from http://en.wikipedia.org/wiki/
Guidance on Qualification of existing facilities, systems, equipment and utilities. Retrieved from
Guideline On General Principles Of Process Validation (2009 April 30). Retrieved from
Code of Federal Regulations Title 21 Part 610 (2010 April 1). Retrieved from