Complya will be participating in the following events:
Wednesday March 14, 2018
Future Trends in Manufacturing and facility tour at MilliporeSigma
If we missed you at these events, we hope to connect with you at a future event!
November 15, 2017
Best Western Royal Plaza Hotel
Meeting 5:30 p.m. to 9:00 p.m.
181 Boston Post Road, Marlborough, MA 01752
with speakers: Milton Boyer and Paul Woitach
Stop by and say “Hi” to the Complya/PharmaLex team at this year’s AAPS 2017 Annual Meeting!
November 12-15, 2017
San Diego Convention Center
111 West Harbor Drive
San Diego, CA 92101
Join us at RAPS Regulatory Convergence
National Harbor, MD
9-12 September 2017
Joint meeting with NEPDA & ISPE
“Validation: The Bridge Between Engineering and Quality Assurance”
with Sylvan Poeckh and Paul Stanovich
Wednesday, May 17, 2017
Meeting 5:30 p.m. to 9:00 p.m.
2 Forbes Road, Woburn, MA 01801
Visit us at booth 204!
33rd SQA Annual Meeting
& Quality College
District of Compliance
Gaylord National Resort and Convention Center
National Harbor near Washington, DC, USA
26 – 31 March 2017
RAPS’ 2016 Regulatory Convergence
September 17-20, 2016
The San Jose Convention Center
408 Almaden Boulevard
San Jose, CA 95110
The Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession’s best and brightest to learn, grow, lead and share.
Visit Complya Consulting at Booth T-9 to learn how we can assist your Regulatory Affairs department.
Join Complya Consulting Group at the 25th Anniversary ISPE Boston Area Chapter Product Show. This year Complya Consulting Group will be exhibiting (C-20) and participating in the Career Fair (E-28).
ISPE Boston Area Chapter Product Show
October 5, 2016
2016 PDA/FDA Joint Regulatory Conference
September 12-14, 2016
Renaissance Washington DC Hotel
For 25 years, PDA and the FDA have collaborated with the common goal of improving the quality of medical products for the American public and providing educational opportunities for the medical products industries. The shared commitment of industry, academia and regulators to deliver high-quality products to patients around the globe serves as the foundation for this collaboration. FDA looks forward to celebrating with PDA the 25th year of this important Conference that will focus on product quality, science and innovation, and lifecycle management, and explore current challenges and opportunities.
Visit Complya Consulting Group at Table 2 to learn how we can assist your Quality Assurance and Regulatory Affairs departments.
News from Complya
August 08, 2017
Reality Bites – Brexit and its Implications for the Pharmaceutical Industry
Written by: Anne Marie Gaffney
Do you have an EU QPPV based in the UK? Do you export pharmaceutical finished product or active substance from UK to European countries? Is your batch release site located in the UK? If yes, then it’s time to take note: Brexit is coming and the reality of the UK leaving the EU is coming into focus for the pharmaceutical industry. The EMA have just released a series of Questions and Answers providing some more clarity on implications.
Unless the withdrawal agreement is extended, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019. The United Kingdom will then become a ‘third country’.
The first notice was published on 2 May 2017, from EMA and the European Commission to marketing authorisation holders of centrally authorised medicines. The intention of the notice was to remind them of their legal obligations in preparation for Brexit.
- EU law requires that marketing authorisation holders are established in the EU (or EEA);
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
On 1st June, the EMA released another regulatory update in response to some frequently asked questions about the impact of the UK leaving the EU. This update sets the tone for what is coming down the tracks.
The document clearly spells out that preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for European and national administrations, but also for private parties.
The following is a summary of implications addressed in the Q&A
- For MAH (market authorisation holder) or orphan designation holder established in the UK, the Q&A clearly spells out the holders must be established in the Union.
- Qualified Persons for Pharmacovigilance(QPPV) must reside and carry out tasks in the Union.
- The location of the Pharmacovigilance System Master File must be located in the Union.
- The location of batch release site must be located within the Union.
- Manufacturing sites of active substances and finished products located in UK will be considered imported active substances and finished products into the EU and as such will be subject to import legislation.
- The issue of access to financial and administrative assistance in accordance with ‘the SME regulation’ is addressed. In order to be eligible, companies must be established in the Union and meet the definition of an SME.
The full Q&A document can be viewed on this link.:
May 16, 2017
Complya merges with PharmaLex
Complya Consulting Group has merged with PharmaLex, a leading specialist provider of scientific affairs, regulatory affairs, pharmacovigilance and development consulting. We are now able to expand our reach and draw upon a deeper bench of resources in order to offer valuable new services to our clients in Boston and abroad.
With this merger PharmaLex Group now has over 650 employees, with 25 offices in 12 countries and more than 600 satisfied clients worldwide.
March 22, 2017
2017 First Quarter Final Guidance Highlights
During the first quarter of 2017 and the FDA has issued a number of drafts and final guidances that effect the pharmaceutical, medical device, and compounding industries. Complya Consulting Group, would like highlight the key final drafts issued in the first quarter of this year.
January 10, 2017
cGMP requirements for Combination Products (21 CFR part 4)
Issued By: OC, CBER, CDRH, CDER, ORA
A combination product is a therapeutic and diagnostic product that combines two or more regulated components (i.e. drug, device, and/or biological products) to produce a single entity whether the components are physically or chemically combined, packaged together or packaged separately; where the components are to be used tougher to achieve the intended use. (21 CFR 3.2 (e)). The final rule on cGMP requirements for Combination Products was issued on January 22, 2013, however prior to this final rule the regulations did not clarify the application of cGMP requirements for combination products since these products cross the lines of the FDA’s medical product centers; CBER, CDER and CDRH. The last draft guidance was issued January 2015 and has been finalized as of January 10, 2017 and is intended to explain the final rule on CGMP requirements for combination products and to specify how to compliance with the applicable CGMP requirements may be demonstrated.
For more information about Combination Products:
January 13, 2017
Interim Policy on Compounding Using Bulk drug Substances Under Section 503A and 503B of the FD&C Act
Issued by CDER
FDA is developing a list of bulk drug substances (“503A Bulk List” and “503B Bulk List”) that can be used in compounding under the section 503A and 503B of the FD&C Act, respectively. For the time being this guidance outlines the FDA’s interim regulatory policy for licensed pharmacists in State-licensed, Federal facilities and for licensed physicians that compound human drug products using bulk drug substance. Bulk drug substances are “the same as active pharmaceutical ingredient as defined in 21 CFR 207.1(b).” The active pharmaceutical ingredient is “any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body,” (503A(b)(1)(A) and 21 CFR 207.3).
February 14, 2017
2017: Significant Changes for the Pharmaceutical Industry
2017 has only started and there are already signs of many significant changes that will impact the pharmaceutical industry and, in particular, GMP. McGee Pharma International (MPI), a proud partner of Complya, would like to bring you an overview of the most significant changes expected this year.
Investigational Medicinal Products (IMPs)
The EU regulation No 536/2014 on clinical trials on medicinal products for human use, which was published in 2014, will become effective as soon as a central submission portal for clinical investigations is established at the EMA.
The European Commission has issued two drafts of delegated regulations in January 2017 and launched public consultation. The grounds for draft development lies in the Article 62 of the EU regulation 536/2014 on clinical trials on medicinal products for human use, which states that the GMP requirements for investigational medicinal products (IMPs) must get revised. Feedback can be submitted until 10th February 2017.
- Commission Delegated Regulation on GMP for Investigational Medicinal Products (IMPs)
- Commission Implementing Directive on GMP for human medicinal products
The aim is to implement separate regulatory requirements for GMP for investigational medicinal products and for GMP for human medicinal products which would replace the existing GMP Directive for human medicinal products 2003/94/EC.
EU GMP Guideline Annex 1 – Manufacture of Sterile Medicinal Products
The EU GMP Annex 1 is currently under revision. Since it was not released in 2016 as planned, the industry can expect public release soon.
Water for injection (WFI)
The European Pharmacopoeia Commission adopted a revised monograph on WFI (0169) which allows for production of WFI by non-distillation purification techniques. The revised monograph will become effective in April 2017. MPI has covered this topic in more detail here and here.
ICH Q3D Guideline for Elemental Impurities.
The dates for implementation of the Guideline are June 2016 for new products (new marketing authorisation applications) and December 2017 for existing products (authorised medicinal products). EMA Guideline “ICH Q3D on Elemental Impurities” (EMA/CHMP/ICH/353369/2013) was adopted in December 2014 and revision of two general monographs of European Pharmacopoeia, “Substances for pharmaceutical use” (2034) and “Pharmaceutical preparations” (2619) followed in 2015.
October 27, 2016
Insights into the 2017 U.S. Regulatory Landscape
In alignment with its mission to protect the public health, the U.S. Food and Drug Administration (FDA) continues to focus on patient safety as a means to that end. As 2017 approaches, the Agency is both loosening and tightening requirements to promote compliance that will result in more informed patients and increased protection to public health. Below are some key updates from the U.S. FDA in 2016, and insights into the 2017 regulatory landscape.
- The pain management industry is experiencing a change in labeling requirements. As a result of a citizens petition filed in February 2016 and under the Opioids Action Plan, the U.S. FDA is now requiring class-wide changes to drug labeling, which include boxed warnings (i.e. the most stringent type) along with patient-focused medication guides for opioids analgesics used in conjunction with benzodiazepines. With the release of a Drug Safety Communication in August 2016, the U.S. FDA aims to inform health care providers and patients of the serious health risks associated with combined used of certain opioids and benzodiazepines, while continuing to combat the prescription opioid abuse epidemic in the U.S.
- The generics industry is also expected to see changes in labeling requirements in 2017 that will allow for generics labels to be non-identical to labels of their brand product counterparts. Under the new requirements (originally proposed in 2013), generics companies in the U.S. will be able to tweak their own labels with updated safety risks. Although the change may be seemingly welcomed by the generics industry, it will create a loophole of increased liability for generics companies. Under the 2011 U.S. Supreme Court ruling, generics companies are currently shielded from accusations associated with patient warnings due to the generics labels being identical to the brand labels. This traces back to the 1992 regulatory requirement based on the U.S. Code of Federal Regulations (21 CFR 314.94(a)(8)(iv)) whereby generics labeling are required to be identical to the reference drug listed. Having different labels from the brand takes generics companies outside the umbrella of this ruling and may have a counterproductive effect, with generics companies being more cautious on labels to mitigate risks of lawsuits.
- In a push for greater transparency, a new clinical trials registration and results ruling goes into effect in January 2017 in the U.S., whereby researchers and sponsors conducting clinical trials are required to provide the public with more detailed information on clinical studies and outcomes. Under the new regulations, for expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), experimenters need to register clinical trials no later than 21 days after the first participant signs up, and need to report the data from the trial no later than 1 year after the completion date of the study. Although there are exceptions to this new requirement (i.e. Phase 1 studies unless sponsored by the National Institutes of Health – NIH), the ruling allows industry to avoid redundancy in studies where is not needed, and more importantly, provides patients a more complete information gateway for on-going trials and high-risk studies.
- U.S. FDA is proposing revisions to the regulations for Good Laboratory Practices for non-clinical studies (21 CFR 58). These revisions revolve around non-clinical testing facilities utilizing a “GLP Quality System”.
Enith Morillo, M.S.
Quality Assurance Consultant
Complya Consulting Group
Key EU Deadlines for Q4 2016 and Early 2017
Complya is proud to partner with McGee Pharma International (MPI) to bring you these EU Legislation updates for the fourth quarter of 2016 and beginning of 2017. This legislation has brought a number of regulatory changes for pharmaceutical companies supplying products in Europe.
Production of Water For Injection (WFI) in the EU by techniques other than distillation
- The European Pharmacopoeia Commission adopted a revised monograph on WFI (0169) which allows for production of WFI by non-distillation purification techniques. The revised monograph will become effective in April 2017.
- Manufacturers who are going to produce WFI by techniques other than distillation methods will need to demonstrate that the new procedure is equivalent to distillation. Furthermore, manufacturers are required to implement efficient control of biofilms and a robust sampling plan.
- A new guidance on production methods for WFI will be also added in the revised Annex 1 ‘Manufacture of sterile medicinal products’ to the EU Good Manufacturing Practice (GMP) guidelines which should be available at the time when the revised monograph on WFI will become effective. A Q&A document is currently being finalized by the GMP/GMDP Inspectors Working Group of the European Medicines Agency.
Process Validation Guideline for Biotech Products
- ‘Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission’ was published by European Medicines Agency (EMA) earlier this year. It is coming into effect on 1st November 2016.
- Companies regulated by the EMA will face a new challenge – a need to implement a lifecycle management approach, i.e., a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
- The guideline provides guidance to the manufacturers on what data they need to include in a regulatory submission to demonstrate that the active substance manufacturing process is in a validated state.
- The Guideline defines two parts of the process validation: process characterization and process verification. While process characterization consists of process development and process evaluation, process verification should confirm that the final manufacturing process performs effectively in routine manufacturing.
April 13, 2016
Complya Consulting & MPI Release Joint Whitepaper on Aseptic Processing
Last fall, Complya Consulting Group was proud to announce a new strategic partnership with McGee Pharma International (MPI), a European GxP consulting firm. This partnership provides a single source of EU and US GxP expertise, allowing for a cohesive approach to global quality, compliance, technical and regulatory strategies.
In celebration of this milestone we are pleased to release a joint white paper written by Ann McGee (Managing Director & Principal Consultant, McGee Pharma International) and Jilla Boulas (Senior Regulatory Affairs Consultant, Complya Consulting Group) entitled: Aseptic Processing: Key Differences Between the EU and US FDA.
To download your free e-copy, .