Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
This PDF describes demo of GMP documents kit which are primary documentation requirements. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
This PDF describes demo of GMP documents kit which are primary documentation requirements. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
U.S.F.D.A. was the pioneer in the concept of process validation.
Validation had proven to be an important tool for quality management of pharmaceutical according to ISO 9000:2000.
Technology transfer from Research and development to productionArchana Mandava
Technology transfer process from R&D to production, Granularity,Complete process from raw materials to finished products, analytical method transfer,Transfer protocol, responsibilities
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
Public Speaking Tips to Help You Be A Strong Leader.pdfPinta Partners
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Org Design is a core skill to be mastered by management for any successful org change.
Org Topologies™ in its essence is a two-dimensional space with 16 distinctive boxes - atomic organizational archetypes. That space helps you to plot your current operating model by positioning individuals, departments, and teams on the map. This will give a profound understanding of the performance of your value-creating organizational ecosystem.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Comparing Stability and Sustainability in Agile SystemsRob Healy
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
Integrity in leadership builds trust by ensuring consistency between words an...Ram V Chary
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
Employment PracticesRegulation and Multinational CorporationsRoopaTemkar
Employment PracticesRegulation and Multinational Corporations
Strategic decision making within MNCs constrained or determined by the implementation of laws and codes of practice and by pressure from political actors. Managers in MNCs have to make choices that are shaped by gvmt. intervention and the local economy.
Enriching engagement with ethical review processesstrikingabalance
New ethics review processes at the University of Bath. Presented at the 8th World Conference on Research Integrity by Filipa Vance, Head of Research Governance and Compliance at the University of Bath. June 2024, Athens
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
CV Ensio Suopanki1.pdf ENGLISH Russian Finnish German
ICH Q7 & Q11
1. Discussion Forum on ICH Q7 & Q11
Scientific & Regulatory Perspectives
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)
2. ICH Q7 & Q11
Scientific & Regulatory Perspectives
7. Outline of the Talk
1. GMP Compliance
Background
Starting Materials
Change Control
2. Common GMP Deficiencies reported
8. Why API production should
comply with GMP?
Review of
some
concepts of
GMP for
APIs
Observed
trends &
deficiencies
during API
inspections
9. Why GMP in API production?
Ensuring the quality of the API greatly
contributes to achieving the objective of
building the quality, safety and efficacy into
the product.
10. Risk based approach in Inspection
(Parameters)
Polymorphism
Solubility in
water
Complexity of
route of Synthesis
Solvents used
Impurities –
genotoxic
Sterile API
Fermentation
Toxicity, Activity,
Potency
Particle size
Site compliance
information
Other properties to be
considered
11. GMP for APIs (ICH Q7): Starting Materials
From what point does GMP for APIs start to be applied ?
– For synthetic process, this corresponds to the
introduction of the API starting material into the
process;
– Stringency of GMP in API manufacturing increases
from early steps to final steps
12. GMP for APIs (ICH Q7): Starting Materials
Advanced intermediates and crude APIs outsourced should
be manufactured in compliance with GMP
– “late intermediate and crude API” manufacturers should
be considered as contract manufacturers
(WHO GMP for APIs chapter 16 applicable)
13. GMP for APIs (ICH Q7): Starting Materials
Sterilization and aseptic processing should be
performed according to GMP related to Sterile
pharmaceutical products.
16. RM, specifications, analytical methods, facilities,
support systems, equipment (including
computerized systems), processing steps,
labelling and packaging materials
That can impact the quality of the API
Proposal drafted, reviewed and approved
by the appropriate organisational unit
17. Change reviewed and approved by QU
Classification and impact assessment
Evaluation and monitoring Notification
19. Critical operation
with prolonged
exposure to the
environment
Non critical operation
with prolonged
exposure to the
environment
Non critical or
critical operation in a
closed equipment
Prevent mix-
ups
Precautions
implemented
Cleaning
methodology
& intervals
Contamination
Risk
assessment
(HVAC)
To prevent
build-up and
carry-over of
contaminants
(degradants)
21. API manufacturer should have
supplier qualification
procedures in place for their
suppliers of critical and non-
critical raw materials, API
Starting Materials, Registered
Intermediates and APIs
(in the case of contract
manufacturers)
an evaluation that provides
adequate evidence that the
manufacturer can
consistently provide
material meeting
specifications
At least
identity testing
of each batch
22. Reduced testing for
approved/validated suppliers
Past quality
history
Full analysis at
least on three
batches before
starting reduced-
testing
Reliability of the
CoA checked at
regular intervals:
a full analysis and
compared with
the certificates of
analysis
23. Precaution for bulk
deliveries in non-
dedicated tankers.
Certificate of cleaning,
testing for trace
impurities, supplier audit.
25. • Blending Operations
– Expiry or retest date of the
blended batch based on the
manufacturing date of the
oldest batch included.
– Should be controlled and
documented – traceability
1. Blending small
batches to ↑se batch size
2. Blending tailings
26. • Blending Operations
– Validation for homogeneity
following blending
APIs for OSDs/Suspensions
1. Particle size distribution
2. Bulk density
3. Tap density
29. Back into the process
Reprocessing by
repeating any step
(crystallization)
Physical or Chemical
Manipulation steps
(Filtration, chromatography,
distillation)
R
E
P
R
O
C
E
S
S
Such reprocessing is not
allowed in majority of the
batches
If so add in Standard Mfg Process
30. Continuation of a process
step after an in-process
control test has shown
that the step is
incomplete.
R
E
P
R
O
C
E
S
S
It is considered a
normal process,
not re-processing
31. Repeating a chemical reaction
and
Introducing untreated material
back into process is re-
processing
However, if it is part of
established process, it is ok
R
E
P
R
O
C
E
S
S
Be careful of
potential
formation of by-
products & over
reacted materials
32. Investigation & reason
of non-conformance
before going for
rework
R
E
W
O
R
K
I
N
G
Careful evaluation, testing
& stability testing,
additional testing
Prove equivalent quality with the
original process
33. • Recovery of Materials and solvents
– Reactants, intermediates or APIs may
be recovered from mother liquor or
filtrates.
– Must use approved procedures and
specifications.
– Recovered solvents may be reused in
same process or in different process if
confirmed to meet appropriate
standards.
– Fresh and recovered solvents and
reagents can be combined if confirmed
their adequacy
1. Approved procedures
2. Suitable specs
3. Adequate testing
5. Use documented
1. No approved procedures
2. Specs – carry over
impurities
3. Not adequately tested
4. Use not documented
36. • Inadequate vendor audit and approval:
– A contractor audit established that the cleaning procedures were
inadequate and the deficiency was classified as critical. As
compliance mechanism, it was decided that the API
manufacturer shall supply organic solvents for cleaning,
however, the solvents were not identified and criteria for their
selected was not high lighted given that the report did not list
the other materials handled on the site.
37. • Inadequate vendor audit and approval:
– The suppliers of key starting materials had not been evaluated
to establish their quality system with respect to the handling of
respective material.
• Furthermore, these materials were accepted based on the
sole supplier's certificate of analysis and there was no
system in place to periodically and independently evaluate
the accuracy of these certificates.
38. • Inadequate control of API starting material (API-SM):
– Block A, where the API-SM was manufactured, was
unacceptable in that,
• Standards of maintenance and house-keeping were unacceptable
including the fabrication of building
– There were many examples of leaks in pipework and process equipment
– The equipment used was unacceptable, both in design and standards of housekeeping
and maintenance.
– No utility or process pipework were labelled
– No QC testing was done on API-SM.
– Specifications for API-SM were due for review July 2010 but
this was never conducted.
39. • Inadequate sampling and storage of materials
– The number of drums sampled for a consignment of 340 drums
of ABC B. No. 123 as recorded on the sampling sheet (5) was
less than that required by the sampling procedure (√N+1 = 19).
– ABC BN 123 was stored in an uncontrolled T° storage area
(same warehouse where staff bus was parked). The
recommended storage condition for this material is below 150C
– API XYZ B. No. 1111 had a release status label dated
09.02.2008 although its manufacturing date was 10.02.2008