InshaAllah will be delivered tomorrow (04 Aug 2018) in a workshop of about 30 participants (Professionals engaged in Pharmaceutical Manufacturing, Engineering, Regulatory & Quality Operations)
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
,
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
,
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
pilot plant is a small system which is operated to find out about the behavior of a process before using it on a large industrial scale. so, this presentation tries to illustrate its objective and significance to understand the methodologies of various pharmaceutical dosage forms.
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.
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.
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
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.
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.
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
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
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.
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/
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
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.
3. This presentation discusses Regulatory Science,
nothing more & nothing less
Reference: US-FDA Documents / Scientific Articles/
Real time hands on experience of Compliance & Enforcement
Personal point of view & nothing to disclose
Disclaimer
5. Source of API is changed …
Can it be caught through testing
If
?
A
6. Impact are possible that may not
caught in end product testing.
What
B
Can you make list please
7. A process of manufacturing (e.g.
from 25 to 30 min mixing to 30
to 35 min mixing) is little
changed.
Do you expect any impact
If
?
C
8. Manufacturing suite is changed for any
operation. E.g. primary packaging
done in area where this product was
not qualified but all including area and
packaging equipment was qualified for
GMP
Can you catch it in testing or any other
stage. Does it have any impact
IfD
9. You can do without any notification to RA
You have to notify RA but approval not required
Approval from RA is required
C
H
A
N
G
E
Make a list
E
F
G
10. If you want to remove assay
& dissolution from end
product testing that you
perform before blister
packaging
Can you do that ?
H
11. If you want to remove assay
of suspension from end
product testing that you
perform before filling
Can you do that ?
I
19. Source of API is changed …
Can it be caught through testing
If
?
A
20. Impact are possible that may not
caught in end product testing.
What
B
Can you make list please
21. A process of manufacturing (e.g.
from 25 to 30 min mixing to 30
to 35 min mixing) is little
changed.
Do you expect any impact
If
?
C
22. Manufacturing suite is changed for any
operation. E.g. primary packaging
done in area where this product was
not qualified but all including area and
packaging equipment was qualified for
GMP
Can you catch it in testing or any other
stage. Does it have any impact
IfD
23. You can do without any notification to RA
You have to notify RA but approval not required
Approval from RA is required
C
H
A
N
G
E
Make a list
E
F
G
24. If you want to remove assay
& dissolution from end
product testing that you
perform before blister
packaging
Can you do that ?
H
25. If you want to remove assay
of suspension from end
product testing that you
perform before filling
Can you do that ?
I
27. Paracetamol
Tablet A global company was manufacturing
Paracetamol Tablets since decades
Found out of specification for
dissolution
Hundreds of batches found OOS
Extensive recall & closure of facility
for 2 years
32. Paracetamol
Suspension A company was manufacturing
Paracetamol Suspension since years
Sedimented product, hard to suspend
Hundreds of batches found OOS in Govt.
supply
Closure of facility for a long period of
time
37. Soft Gelatin
Capsule A global company was manufacturing
different products in soft gelatin capsules
since decades
Disintegration failed n one product, drug
not released
Hundreds of batches of millions of
capsules recalled
Closure of facility for 2 years
42. Zinc Sulphate
Solution
Did not meet specifications for
its pH as mentioned in USP
They developed their own
specification (ZSO4 syrup)
Govt. Supply batches failed
67. Evaluation of change
Approval to proceed with the change
Implementation of change
Review to ensure that change has been effective
SOP
for every step
68. Evaluation of change
Approval to proceed with the change
Implementation of change
Review to ensure that change has been effective
Review effectiveness of overall system
SOP
for every step
73. Probability, Severity & Detectability
Use of prior knowledge – development, other
manufacturing locations, similarities with other
products
Use Risk
Management
Tool in Change
Cycle
74. Probability, Severity & Detectability
Use of prior knowledge – development, other
manufacturing locations, similarities with other
products
Output should include understanding of adequacy
of control & additional ones as necessary
Use Risk
Management
Tool in Change
Cycle
75. Ensure change management system in place
Ensure IT system for change management validated
Approved change - lifecycle dependents
Audit impact of change & review effectiveness
Assure safety & quality of product
Quality Unit
Role
76. Scope of change management must
not cross the boundary of regulation
and must be within the space of
authorized company Quality System
Scope
77. Lets think
A company wish to change dissolution profile of its product
Can they do?
78. Lets think
A company wish to change dissolution profile of its product
Can they do?
No
79. Lets think
A company wish to remove manufacturing date from the label
Can they do?
80. Lets think
A company wish to remove manufacturing date from the label
Can they do?
No
86. Lets think
A company wish to change supplier of raw material (API)
Can they do?
Yes
87. Lets think
A company imports finished goods from site A of Country
Holland. They wish to change Manufacturing site from A to
B of the same country. A & B are the sites of the same
manufacturer.
Can they do?
88. Lets think
A company imports finished goods from site A of Country
Holland. They wish to change Manufacturing site from A to
B of the same country. A & B are the sites of the same
manufacturer.
Can they do? No
89. Particulars Inspection Review
API FG Manufacturer FG Manufacturer
FG Regulatory Authority Regulatory Authority
Container Closure ??? ???
Bioavailability Site ??? ???
Machine ??? ???
Primary Responsibility
RA can extend …
91. Why
Change?
It is not the strongest of
the species that survive,
nor the most intelligent,
but the one most
responsive to change
92. ICH Q10 & Change
Management
A systematic approach to
proposing, evaluating,
approving, implementing and
reviewing the change
93. ICH Q10 & Change
Management
Change management is a
much boarder scope than
change control
94. ICH Q10 & Change
Management
CM includes the oversight &
management of the entire
portfolio of change & the
change process including all
components of change control
95. ICH Q10 & Change
Management
CM applies across the entire
product lifecycle
97. CMS
The level of efforts & formality of the
evaluation should be commensurate with
the level of risk
QRM should be utilized to
evaluate the proposed changes
98. CMS
Current product & process understanding
… design space well established
Proposed change should be
evaluated
125. Unpredictable
Mfg
If you do not take advantage
of contemporary technology
Frequent start & stop to
correct problems & to pull
samples (e.g. tablet, sterile
Mfg. lines)
136. It is your choice to go for quality
or manage undocumented
Your decision influence
your direction & ultimate
destiny
Imagine
How many decisions
you take daily?
How much directions
you receive verbal/
phone/ face
137. It is your choice to go for quality
or manage undocumented
Your decision influence
your direction & ultimate
destiny
Imagine
How many decisions
you take daily?
How much directions
you receive verbal/
phone/ face
139. Quality
Culture
Support for the Quality Organization
Action speaks louder than words
Quality of work you accept becomes your
standard
QA is independent & not subordinate to
other organizational units
140. Memorandum
… EU
The manufacturer shall establish &
implement an effective
Pharmaceutical Quality Assurance
System involving the active
participation of the management &
personnel of the different
departments
141. Memorandum
… FDA
when it employs conditions &
practice that assure compliance ..
with the intent of … cGMP
regulations that pertain to
their system
A manufacturer is
considered to be operating in
a state of control ..
142. Memorandum
… FDA cGMP includes the implementation
of oversight & control over the
manufacture of drugs to ensure
quality, including managing the risk
of and establishing the safety of raw
materials, the materials used in
manufacturing of drugs & finished
drug products
143. Memorandum
… FDA The system which assures overall
compliance with cGMP and internal
procedures & specifications is
certainly the Quality System
Remember, Quality System is not
only undertaken by QA/QC, it
involves many other responsible
departments
144. Be Aware
Please If the management of the firm is
unwilling or unable to provide
adequate corrective actions in an
appropriate time frame …
Formal regulatory actions designed
to meet emerging situations
encountered are taken
146. A condition in which the set of
controls provide assurance of
continued process performance &
product quality
(ICH Q10)
What is
State of Control
147. After establishing & confirming the
process, manufacturer must
maintain the process in a state of
control over the lifecycle of process,
even as material, equipment,
production environment, personnel
& manufacturing procedure changes
(FDA, PV Guidance 2011)
Don’t Forget
148. Technology transfer is insufficient to support
desired commercial operation
Is it GMP Compliant
?
151. Excessive variation due to outdated
production technology ….
Major manufacturing & quality
problems
Never consider innovations
Manufacturing going on
Is it GMP Compliant
?
Take a
Scenario
153. Any CHANGE in procedure for production &
process control designed to assure identity, strength,
quality & purity shall be approved by the appropriate
organizational unit & reviewed & approved by the
Quality Control Unit
Manufacture
154. Any change in such specifications, standards,
sampling plan, test procedures or other laboratory
control mechanisms shall be drafted by the
appropriate organizational unit & reviewed &
approved by the Quality Control Unit
Laboratory
155. Manufacturer must review at least annually the
quality standards of each drug product to determine
the need for change in drug product specifications, or
manufacturing or control procedures
Improvement
156. Manufacturer must review at least annually the
quality standards of each drug product to determine
the need for change in drug product specifications, or
manufacturing or control procedures
Improvement
The best way is to document why it is required
or why it is not required
157. Innovation, continual
improvement, outputs of process
performance & product quality
monitoring, CAPA drive change.
To evaluate, approve & implement
these changes properly, a company
should have an effective change
management system
Change
Management
158. Design
OOS results may indicate a flaw in
product or process design, for e.g.
A lack of robustness in
product formulation
159. Design
OOS results may indicate a flaw in
product or process design, for e.g.
Inadequate raw material
characterization or control
160. Design
OOS results may indicate a flaw in
product or process design, for e.g.
Substantial variation introduced
by one or more unit operations of
the manufacturing process
161. Design
OOS results may indicate a flaw in
product or process design, for e.g.
A combination of these
factors can be the cause of
inconsistent product quality
162. Design
Product & Process re-design
need to be undertaken to ensure
reproducible product quality
Re
163. The process is not monitored for
process performance
Is it GMP Compliant
?
164. The process is not monitored for
product quality
Is it GMP Compliant
?
165. The process is not monitored to see &
maintain the State of Control
Is it GMP Compliant
?
167. Building
Knowledge
To develop & use effective
monitoring & control system for
process performance & product
quality, thereby, providing assurance
of continued suitability & capability
of process
ICH Q10
168. Do engage in real time
for continued process
verification by scrutiny
of inter-batch & intra-
batch variations
Inter-Batch Intra-Batch
169. Qualified person or Responsible Person is not
aware of major product quality problem (e.g.
Complaints, Returns etc.)
Is it GMP Compliant
?
170. Remember
Please
Procedure must be established to
assure that responsible officials of
the firm, if they are not personally
involved in or immediately aware
of such actions are notified in
writing of any investigation
conducted under obligations
171. Remember
Please
Ensure a timely and effective
communication & escalation
process exist to raise quality issues
to the appropriate level of
management
172. The manufacturer routinely reacts to the
production failures by making corrective actions
but does not take any preventive actions
Is it GMP Compliant
?
173. Prevention
Prevention from contamination,
loss of process control, error, defect,
deviation, uncertainty, inconsistency,
mix up potential
It is basic theme and purpose of
cGMP regulations
175. You are the owner & applicant for a
multi-use ophthalmic product
You learned that your contract
manufacturer has received a
complaint that 2 batches contained
leaking containers
Cont’d
Take a
Scenario
176. This contract manufacturing site
produces batches for you when you
cannot meet the demand at your site
The 2 lots have already been
distributed
The investigation of the complaints
include testing of retaining sample
Cont’d
Take a
Scenario
177. You learned from testing that 3 other
lots produced over the last 2 years
have a significant number of leakers
You had qualified the facility solely
by testing the first 3 lots it produced
Is it GMP Compliant
?
Take a
Scenario
178. Management does not provide adequate &
appropriate resources (human, financial, material,
facilities & equipment) to sustainably meet
cGMP in order to maintain robust operation
Is it GMP Compliant
?