Tuesday, 14 August 2018

Important Packaging Trends in the Pharmaceutical Industry


You’d be hard-pressed to find an industry that isn’t currently seeing a form of evolution or transformation thanks to the variety of modern technologies entering the playing field. The pharmaceutical industry is no exception, and neither is packaging development in the space.

A guest post by Megan Ray Nichols

From a CX standpoint, consumers now expect and demand more accurate, enhanced personalization opportunities with faster — somewhat unheard of — delivery and fulfillment speeds. This is in addition to more stringent and traceable DSCSA standards and requirements. Naturally, quality management and reliability are still high priorities as well.

All of this culminates in a growing need for better, more efficient, more reliable and more capable packaging and development needs. It is driving the emergence, growth and boom of many new trends all across the industry.

1. Personalized Care Is Becoming More Necessary

Consumer demand is both expanding beyond legacy requirements and evolving at the same time. It is expanding because the current climate has allowed for regulatory and experience changes. The Affordable Care Act, or ACA, for example, provides insurance accessibility to even more American citizens, thus increasing the demand for pharmaceuticals.

Many populations are aging at the same time, increasing pharmaceutical and healthcare demands beyond anything that’s existed in the past.

But perhaps the most difficult element in all of this is the need for more personalized medicine. A one-size-fits-all approach is no longer applicable in any industry, really, brought on by modern technology and instant fulfillment opportunities. With the single tap of a digital button, consumers can order pharmaceuticals via mobile from anywhere. This expands to prescription-based meds, even, where connected patient and doctor systems facilitate the need for instant-fill methods.

As a result, pharmaceutical packagers must learn and adapt to deliver continuous, localized production streams in fewer batches and with shorter lead times. The smaller the batches get, the greater the need to package the goods closer to the consumer.

2. Smart Packaging for Identification, Patient Management and Increased Transparency


Smart labeling technologies have emerged to supplement many of the issues plaguing the current pharmaceutical packaging market, especially when it comes to DSCSA regulations on serialization, transparency and accountability.

Smart RFID tags can be used, in addition to barcodes, to track and monitor pallet-level goods throughout the supply chain. They’re incredibly efficient because you can verify an entire truckload of goods without patrolling through the entire stock. Of course, it also helps improve security and transparency and prevent tampering, because the packaging and goods within can be tracked, in full, across their entire journey up until distribution.

NFC tags or labels are also being used — embedded within packaging labels — to allow for modern scanning opportunities. This is especially helpful for patients, who can simply tap an NFC-enabled smartphone to the packaging and receive information about dosages, quantity and even refills. On the business side, NFC interactions can be tracked to learn a little more about the customers.

3. Accountability Is Vital

Driving the need for many of these smarter, more connected technologies is a looming requirement of accountability and transparency. The Drug Supply Chain Security Act — or DSCSA, as we’ve been referring to it — expressly requires federal verification, serialization and monitoring of all transactions or exchanges when it comes to pharmaceuticals. This makes it vital to protect, secure and track all shipments and transactions in full to protect your own company.

Not that it’s not important to do this anyway. Counterfeit pharmaceuticals, for instance, are a huge problem globally. And although it’s more common for them to be faked at the development and manufacturing stages, it’s entirely possible for shipments of real drugs and goods to be swapped for the faux kind while in transport. This is even more likely when dealing with third-party transporters and distributors for your goods.

There’s also the matter of proper packaging to ensure the quality and health of those affected. Medicine bottles, for instance, notoriously use special plastic molding to produce locking mechanisms which are childproof and secure. To prevent harm, and even litigation, it may be necessary to monitor and track certain types of bottles to ensure the seal and security is maintained.

Setting up a proper tracking and accountability system ensures that all packaging can be properly authenticated and monitored en route and beyond.

4. A Stronger Focus on Data Management and Cybersecurity


In order for the systems involved to become smarter, and for those connected devices to report useful information, the exchange of digital data has to happen. This also means more and more data will be generated, stored and processed within the pharmaceutical supply chain. Where there’s data, there are vulnerabilities and open devices ripe for attack.

Robust, integrated and well-maintained data security systems are necessary to protect any and all data management and reporting systems. Most importantly, they must help companies and providers prevent counterfeiting, security breaches, data tampering and theft.

This is especially true of any data related to the supply chain, which must always be verified and trustworthy. You want to be able to look at the current or past location of a shipment and know that’s exactly where it is — with access to a data stream where it’s difficult to change or alter such information.

5. The Inevitable Rise of Contract Packaging

As you’ll notice, the market is much more stringent when it comes to regulations and requirements, putting a tighter leash on pharmaceutical companies to properly handle packaging. Many of these regulations render legacy equipment and strategies obsolete. Smart labels, for instance, are essentially required to ensure proper tracking and accountability.

As a result, these companies are turning to specialized contract packagers, or CPs, to get the work done properly. Because they have newer equipment, they can get the work done faster, safer and more accurately. This also eliminates the burden big pharma companies have with respect to packaging, meaning they can focus on core competencies instead.

Furthermore, outsourcing the packaging process can help reduce supply chain costs by as much as 25 to 50 percent. This further alleviates costs associated with packaging and general shipment preparations, making it that much more lucrative to big pharma companies.

Evolve or Fail


Make no mistake: the landscape is changing rapidly, which means many of these trends will soon be the industry norm. That’s exactly why pharmaceutical packagers want to remain on the frontline, adopting new label technologies, tracking and accountability opportunities, and quality management processes as soon as possible. This is in addition to compliance and regulatory requirements that are — or could — threaten your business should you fail to keep up.

For a competitive advantage, you must evolve and adopt these growing trends — it’s as simple as that.

Pharmaceutical Microbiology

Monday, 13 August 2018

Selection of microbial monitoring locations on personnel


Having a documented rationale for the assessment and review of the personnel monitoring locations is important for the microbiologist should understand why certain locations are monitored and what the data relating to each individual site means, especially when action level excursions occur and investigations need to be executed. Such a document also serves as a justification to present to auditors or inspectors.

In relation to this, a new paper has been published. Here is the abstract:

The assessment of personnel working in aseptic processing areas, whether this is for supporting Grade B (ISO class 7 in operation) or more critical Grade A (ISO class 5) activities is an important part of the environmental monitoring programme. Guidance from regulators is limited as to how and when personnel monitoring is performed, especially in relation to the locations to be selected on the cleanroom gown. In this paper we examine the potential sites for monitoring and provide a risk-based rationale for the most appropriate sites. The intention is not to provide a defined approach that every aseptic processing facility should adopt; instead we offer a schematic that other organisations can consider, to either base their own operator sampling regime upon or to benchmark their own monitoring regime against. This is on the expectation that regulators expect personnel monitoring locations to be defined and justified.

The reference is:

Satyada, R. and Sandle, T. (2018) Rationale for the selection of microbial monitoring locations on personnel working in aseptic processing areas, European Journal of Pharmaceutical Science and Technology, 23 91): 17-23

For details, contact Tim Sandle

Posted by Dr. Tim Sandle

Sunday, 12 August 2018

Markers, erasers, and germs


A thorough, terminal cleaning of hospital rooms between patients is essential for eliminating environmental contamination, and a checklist is a standard tool to guide the cleaning staff. But new research presented at the 45th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC) offers an important reminder that the checklist is only as good as the list itself.

The environmental services team at Summit Health, a hospital in rural Pennsylvania, used a 175-item checklist in 2017 to guide terminal room cleaning. The list included the dry-erase white boards used for communications. However, it did not include the markers or the erasers.

In an inspection of 55 cleaned and prepared patient rooms, 39 markers and 52 erasers were identified and tested for the presence of Adenosine triphosphate (ATP), an indicator for the presence of biological residues. Not a single marker and only two erasers passed the test.

This was in stark contrast to the more than 95 percent of checklist surfaces that passed.

“Although they are just small writing instruments, both the markers and erasers tested at 40 times the threshold,” said Ericka Kalp, PhD, MPH, CIC, FAPIC, lead study author and director of epidemiology and infection prevention at Summit Health. “Because these are a main communication tool for nurses, cleaning them properly is of great significance to improving infection prevention.”

The ATP testing was performed with environmental services staff in attendance. If results were over the threshold, the infection preventionist conducting the test then demonstrated how to properly clean and retest.

“Environmental cleaning is essential to preventing the spread of infection,” said 2018 APIC President Janet Haas, PhD, RN, CIC, FSHEA, FAPIC. “This study emphasizes the importance of not only using a checklist as a reminder of what needs to be cleaned, but also making sure the list includes all frequently touched items.”


Summit Health has utilized the 175-item checklist since 2012. Both the markers and the erasers have since been added to the checklist.




Posted by Dr. Tim Sandle

Saturday, 11 August 2018

Nurses: The missing link in antimicrobial stewardship strategy


Empowering nurses to participate in antimicrobial stewardship programs (ASPs) is the missing link in strengthening hospital-wide antimicrobial stewardship and improving patient care, according to a new study presented at the 45th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC).

The research, conducted at Jefferson Health in New Jersey, shows that ASPs are strengthened by educating nurses about antimicrobial stewardship and obtaining their buy-in.

“Our findings show that nurses have been overlooked and under-utilized in ASPs,” said Jefferson Health – New Jersey Infection Control Officer Cindy Hou, DO, MA, MBA, FACOI, the study’s lead author. “Changing the culture and empowering nurses to speak up about antimicrobial stewardship leads to closer team coordination and cross-discipline collaboration, which ultimately saves lives.”

A 10-question quiz on antibiotic usage found that nurses were generally not comfortable with microbiology reports or familiar with the unique features of different antibiotics. A baseline assessment found that 93.8 percent of nurses incorporated microbiology results during sign-out reporting, but only 50 percent checked susceptibility results of cultures before administering antibiotics. What’s more, only 65.1 percent of clinical nurses notified physicians if cultures showed resistance.

Nurse buy-in was achieved by engaging chief nursing officers at Jefferson’s three New Jersey hospitals, opening up participation in ASPs to nursing leadership, educators, performance improvement, and infection control staff.

Materials were written in “nurse speak” and integrated into the typical nursing work flow to promote usage.

“Multidrug-resistant organisms cause a significant proportion of serious healthcare-associated infections and are more difficult to treat because there are fewer and, in some cases, no antibiotics that will cure the infection,” said 2018 APIC President Janet Haas, PhD, RN, CIC, FSHEA, FAPIC. “This study shows that by engaging with nurses and pushing for greater team collaboration, major progress can be made on ASPs, which is essential to help reduce the threat of antibiotic resistance.”


Posted by Dr. Tim Sandle

Friday, 10 August 2018

Technical Guide on 2D Measurement System


A useful guide on improving productivity with the Image Measurement System. It includes implementation examples and customer reviews about the benefits of
  • Automatic report generation,
  • Unified measurement results regardless of the user ,
  • Simple operation. 


Download the Image Dimension Measurement Guide here

Posted by Dr. Tim Sandle

Thursday, 9 August 2018

Revised PIC/S guidances


Revision of PIC/S GMP guide has been announced:  Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised and will enter into force on 1 July 2018; along with adoption of transposition for PIC/S purposes of EU guidances on GMP excipient risk assessment, exposure limits and GDP for API.

The details are: 
  • Chapter 3 on “Premises and Equipment”;
  • Chapter 5 on “Production”;
  • Chapter 8 on “Complaints and Product Recall”. 
The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by revised Chapter 5. Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised.

See: PIC/S



Posted by Dr. Tim Sandle

Wednesday, 8 August 2018

Pharmig News #72


A new edition of Pharmig News has been issued. In this edition:
  • Pharmig events update
  • Review of Pharmig Irish conference and risk management by Tim Sandle
  • Brexit uncertainty by Tim Sandle
  • Latest regulatory news
  • And more!

Copies will have been sent to member organisations. To see a copy, please email Pharmig at: info@pharmig.org.uk

Tim Sandle's articles in this edition are:

Sandle, T. (2018) Microbiology Risk Management (QRM): a practical approach meeting, Pharmig News, Issue 72, pp2-4

Sandle, T. (2018) Brexit uncertainty for pharmaceutical companies, Pharmig News, Issue 72, pp5-6



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 7 August 2018

Annex 16 Q&A – Unexpected deviation


Annex 16 Q&A – Unexpected deviation: what is the Role of the QP? With this guidance document the EMA has updated its Q&A on Annex 16 to further clarify the role of the QP in the context of handling unexpected deviations.

The new questions are:

1. Can a site have more than one QP performing certification of batches?

2. Can there be more than one QP involved in the certification of a given batch?

3. In the context of handling unexpected deviations, what is included in the scope of registered specifications for medicinal products? / What is an ‘unexpected’ deviation? / Does Annex 16 permit QP certification of more than one batch affected by the same unexpected deviation?

In Europe, the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).

Reference: EU GMP

Posted by Dr. Tim Sandle

Monday, 6 August 2018

Tonsils in Children: Should They Be Removed or Not?


One of the hardest things for a parent to endure is to watch their child undergo a surgical operation. To see their beloved child in pain, lying in the recovery ward; it almost makes them think about whether or not the procedure was worth it.

A guest post by Angel Jeslie "AJ"

The question on why children should undergo surgery isn’t new. However, it’s still widely discussed to this day. About 530,000 children under 15 years of age in the US have tonsillectomies each year.

Tonsillectomy is the second most common surgical procedure that children encounter, and it entails a precise removal of the tonsils. Typically, they have the procedure done between the ages three and seven.

Tonsils are masses of tissue located inside the mouth behind the nasal passages. Their purpose is to act as the first line of defense against bacteria and germs by activating the body’s immune system early.

Due to the entry of bacteria, the tonsils can become infected. The resulting inflammation that occurs; known as tonsillitis, generates symptoms such as a sore throat, fever, bad breath, and difficulty breathing. However, one of the most common misconceptions is that children undergo tonsillectomies as a treatment for tonsillitis, when in fact the majority of operations are to combat sleep apnea.

The Benefits

Between the ages of 2 and 7, a child’s tonsils can become enlarged and cause a partial obstruction of their airway. Enlarged tonsils are the main cause of sleep apnea, which is the condition wherein a child snores and has irregular breathing patterns at night.

According to researchers at the University of Michigan, children that snore regularly could be more prone to having Attention Deficit Hyperactivity Disorder (ADHD). By having their tonsils surgically removed, children are able to sleep better and snore less.

The disruption of a child’s breathing at night can reduce the amount of oxygen which enters their brain and lead to a number of symptoms like daytime irritability, difficulty waking up, and morning headaches. Getting a tonsillectomy done will improve a child’s sleep and avoid the secondary symptoms from surfacing.

Enlarged tonsils can also cause bedwetting even for children that are already toilet-trained. Because of the extremely deep slumber that sleep apnea elicits, they can easily lose bladder control while in bed. Removing the enlarged tonsils will allow them to get a good night’s rest and they should be able to get back to their old training in no time.

Tonsillitis can be a reason to have tonsils removed but it’s not the primary one. According to the American Academy of Family Physicians, tonsillectomy is recommended for children who have experienced at least 7 episodes of throat infection in the past year, more than 5 throat infections per year for the last 2 years, or more than 3 episodes per year for the past 3 years.

The Drawbacks

Although tonsillectomy has plenty of benefits for children, the downsides also need to be considered.

Tonsils in children usually grow to a maximum size by the age of 12 and begin to shrink at around 20 years old. After that, they play no useful role within the body. As with any type of surgery, there is an element of risk and some of these include potential bleeding, swelling, infection, or adverse reactions to anesthetics.

Bleeding after surgery can occur for 3 – 4 percent of children. If it does happen, it usually starts around a week after the operation. But in some cases, it can occur as much as two weeks later. This will normally warrant a trip back to the hospital.

Bleeding mostly stops by itself but in a few infrequent cases, a second surgery may be needed to cauterize the wound. This entire ordeal can be unpleasant for children as they will be dealing with immense pain in the mouth. Morphine or a prescribed painkiller may be needed to help them cope.

Postoperative symptoms frequently include a fever, while some children experience ear pain. White plaque can form at the back of the throat and scabs may be visible in the throat. Bad breath is another common symptom and is totally normal for a child that has just had his/her tonsils removed.

For a short time after the surgery, it will be difficult to eat due to the pain involved with swallowing. Soft foods are advised such as gelatin, soup, cold slushies, or milkshakes. Ice-cream can be given as a reward for good behavior.

After a few days, they can advance and eat a bit more varied foods such as mashed potatoes or pudding. Avoid spicy or citric foods as these will irritate the back of the throat more and cause discomfort.

Summary


It is important to note that there are no permanent disadvantages to tonsillectomy and most of the symptoms which manifest after surgery only last for a couple of weeks, at most. A doctor can help evaluate a child to isolate if a tonsillectomy is necessary; but in the end, the decision falls to the parents. Carefully weigh the risks versus the benefits of carrying out the procedure.

Pharmaceutical Microbiology

Hepatic steatosis versus normal liver in optical microscopy


A new article of interest:

The aim of the study is to present structural characteristics referring to the normal liver
comparing with structural particularities from liver at patients diagnosed with hepatic steatosis. For this purpose of the present study, were analysed microscopic aspects of hepatic structures in hepatic steatosis by comparison with normal liver. From this point of view, the study aims mainly observing the hepatocyte cords and their modifications, like lipid deposits in hepatic steatosis, and less the presentation of vascular components, which are not of major importance in hepatic steatosis compared with normal liver. Knowing the impact of hepatic steatosis on health, the present morphological study, show structural characteristics to liver diagnosed with hepatic steatosis versus structural characteristics to normal liver.
The reference is:


Chesca, A., Sandle, T. Babenko, D. and Azizov, I. (2018) Hepatic steatosis versus normal liver in optical microscopy, Annals of Romanian Society for Cell Biology Vol. XXI, Issue 3: 58 – 62

The article can be found here: Hepatic

Posted by Dr. Tim Sandle

Sunday, 5 August 2018

New PDA e-book


A new e-book has been issued by the PDA, entitled “Environmental Monitoring, Volume 1: Establishing the process’.

The book features contributions from Barry A. Friedman, Karen Ginsbury, Sandra A. Lowery, Maureen Mueller, Tim Sandle and Frank Settineri.

For details see: PDA

Reference:

Friedman, B.A., Ginsbury, K., Lowery, S. A., Mueller, M., Sandle, T. and Settineri, F. (2017) Environmental Monitoring, Volume 1: Establishing the process, PDA / DHI books, Bethesada, U.S.

The book contains a chapter by Tim Sandle:

Sandle, T. (2017) Environmental monitoring: a practical approach’. In Friedman, B.A., Ginsbury, K., Lowery, S. A., Mueller, M., Sandle, T. and Settineri, F. (2017) Environmental Monitoring, Volume 1: Establishing the process, PDA / DHI books, Bethesada, U.S., pp23-48

Posted by Dr. Tim Sandle

Saturday, 4 August 2018

Harmonisation in the classification of medicines


The Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them, as listed in the database. The new Resolution CM/Res(2018)1, which supersedes the previous Resolution ResAP(2007)1 from 2007, will continue to play a key role in providing 800 million citizens across Europe with safe access to medicines and to support national authorities in ensuring the appropriate and responsible use of medicines.

The classification of medicines has implications in terms of patients’ safety, accessibility to medicines and healthcare expenditure. It also determines the level of control over the supply of a medicine and has a direct impact on patients’ access to treatments. The objective of the revised Resolution is to support the development of uniform and safe supply conditions for medicines for human use across Europe and to harmonise legislation at national level.

The information provided by national authorities is included in the Melclass database, which is hosted by the EDQM and coordinated by its Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO). The database also contains the recommendations on the classification of medicines that the Committee issues to health authorities in Member States with a view to harmonise requirements for the supply of medicines across Europe.


The revision of the Resolution was carried out by the CD-P-PH/PHO with the oversight of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The new Resolution CM/Res(2018)1 on the classification of medicines as regards their supply was adopted at the 1313th meeting of the Committee of Ministers of the Council of Europe.

See: EDQM

Posted by Dr. Tim Sandle

Friday, 3 August 2018

Monograph for Water, highly purified (1927) to be suppressed


Following a decision taken by the European Pharmacopoeia (Ph. Eur.)  Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.


Source: EDQM



Posted by Dr. Tim Sandle

Thursday, 2 August 2018

New technical specification for auditors of ISO 45001




ISO 45001, Occupational health and safety management systems – Requirements with guidance for use, made standardization history when it was published in March this year. Now, a new complementary technical specification – ISO/IEC TS 17021-10 – has just been published, defining the required skills and knowledge of those bodies auditing organizations that have implemented the health and safety standard.


ISO/IEC TS 17021-10, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 10: Competence requirements for auditing and certification of occupational health and safety management systems, is intended to guarantee a harmonized approach to the accreditation of an ISO 45001 certification.

The new technical specification is aimed at auditors, or anyone making certification decisions related to ISO 45001, and will ultimately serve certification, accreditation and regulatory bodies by confirming that auditing and certification decisions related to ISO 45001 have been carried out by those who have the competence to do so.



Posted by Dr. Tim Sandle

Wednesday, 1 August 2018

Link between bacteria metabolism and communication


Researchers have discovered a link between bacteria metabolism and cell-to-cell communication, potentially providing a target for new antivirulence and antibiofilm drugs.

Current drugs for bacterial infections aim to kill bacteria in large quantities, but such drugs are often eventually met with antibiotic resistance. Antivirulence and antibiofilm drugs, on the other hand, block toxic molecules produced by bacteria or prevent bacteria from forming thin, slimy films called biofilms (a common example is dental plaque). These mechanisms are controlled by quorum sensing: the process that allows bacteria populations to communicate and coordinate group behavior.

For example, biofilm forming E. coli can cause urinary tract infections. Thus, disrupting quorum sensing and biofilm forming in the bacteria could prevent those infections.

Quorum sensing is facilitated by signaling molecules called autoinducers. One particular autoinducer, AI-2, is modified by a protein called LsrK so that its signal can be perceived.

The findings, which were published in the journal Science Advances, shows that LsrK forms a complex with HPr, a protein involved in glucose utilization in E. coli.



 Posted by Dr. Tim Sandle

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