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17.05.2014 admin
We are very hands-on (Montessori-ish) homeschoolers and have been homeschooling for four years, headed into our fifth! So many people think Montessori homeschooling is akin to chaos or unschooling without structure… But that is just not accurate, as you will see with the boys’ curriculum and schedule! We have gotten a bit creative in how we encourage the boys to grow their writing skills… we allow them to blog about their businesses and our homeschool on our homeschool blog. All of our boys have a focus and desire to go to college, so you will notice they are pretty aggressive in their workload.
I can assure you, we don’t have homeschooling or child-rearing figured out, but we are in a pretty good place right now.
Trish has been married to her best friend, David, for 16 years and they have three sons (aged 13, 12 and 9). Hope to hear from you… and anybody interested in homeschool Spanish classes for their youngsters. I love looking at what other parents are doing in their homeschools, especially with their 7-9th graders. We also incorporate free work time in our day and they let me know their plans for time management and their focus. The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities.
The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances. The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5).
The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015.
The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA.
This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”.
The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.


From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP).
The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances.
Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines.
The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).
EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture.
The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S.
As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014. The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs.
The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market.
The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country.
Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products. According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally. This article is all about our homeschool curriculum, schedule and checklist for 2013 -2014. You will see on the boys’ daily checklist a variety of daily chores they do from vacuuming to washing clothes.
All comments on our blog are moderated by me and all of their emails forward to me, so it is very controlled and protected (as much as they can be in this fallen world). Trish is from the coast of North Carolina, but they now live in rural West Tennessee on a 40+ acre farm. The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland. Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions.


The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products".
The report has been presented in a revised format, following comments from a stakeholder focus group.
Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.
According to the EC this became necessary due to changes in various Annexes of the GMP Guide.
FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. I have included with each of my sons’ curriculum section, their schedules and their daily checklists (which includes their home chores). And we regularly swap out chore lists to allow for the boys to learn all aspects of running a home. The boys are really loving this new avenue of communication with the outside world called social media! She has been homeschooling since 2009 and her homeschool style leans towards a Montessori approach with a heavy emphasis on hands-on learning. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
Thankfully our umbrella school, HomeLife Academy makes it easy with their new AppleCore Reporting System!
Montessori focuses on independence in education and the realization that we are life long learners.
We have also taken practical life skills to the next level with a focus on entrepreneurship.
It will be a part of their world when they are grown, so we might as well teach them how to use it responsibly now! Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). The tools we are using (schedules and daily checklists) are very effective at keeping them on track, holding them accountable and giving them freedom within their daily schedule. Trish’s family is Messianic and they love studying the Scriptures, learning Hebrew and growing in their faith and walk daily.
She is finishing 7th grade proper, will be beginning 8th grade week after next, but she has run ahead on science and has done all my planned science curriculum up to 9th grade.
Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. We believe they will be the generation that gets America back on the right track, from a spiritual, economic, moral, government and academic perspective. My yougest son wanted to do algebra in 3rd grade because he was chasing his older brothers.
In her spare time, Trish loves to write, work in their garden and can regularly be found trying to learn something new, modeling that learning is indeed a life-long endeavor!
With the exception of those virtual or co-op classes that have specific times that the boys must attend at a specific time, we allow them to do their work at any time each day, as long as it is done that day. He has since just completed the Teaching Textbooks Pre-Algebra curriculum (in third grade) and has started the Teaching Textbooks Algebra before entering 4th grade. Let them run and only slow them down if they are setting themselves up for a huge failure that you know they would not recover from. However, if we urban, they might not have these same businesses, but they would have some sort of business to teach them about capitalism!
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