1) Recalls and returns are a fundamental element of good manufacturing practices and ensure that defective products are removed from the market.
2) Manufacturers are obligated to initiate a recall if one is necessary to protect public health, and regulatory authorities may order a recall.
3) It is important to monitor a recall closely and maintain thorough records to ensure its effectiveness in removing defective products from distribution and use.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
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NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
Understanding Pharmacology for Health Professionals 4th Edition Turley Test BankEmilyVaughanss
Full download : https://alibabadownload.com/product/understanding-pharmacology-for-health-professionals-4th-edition-turley-test-bank/ Understanding Pharmacology for Health Professionals 4th Edition Turley Test Bank , Understanding Pharmacology for Health Professionals,Turley,4th Edition,Test Bank
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
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.
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.
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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.
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Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
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.
1. Recall & Returns; Fundamental Element of GMP
Will it work when required?
A Regulatory Perspective
Roohi B. Obaid Dec 1st 2018
2.
3. It is based on experience and explanations reflects the views and
understanding of presenter & may not be construed to represent
the views or policies of organization or association to which
speaker has ties
Disclaimer
4. Return of distributed good
from market
Market includes distributor
Market includes pharmacies
Market includes consumer
Risk will scratch the word
market
Re call
17. A damage that does not have
impact on quality of product
may be allowed to reenter in
the market after its re-dressing
or cosmetic make up.
Re-dressing does not mean
exposure of drug. It means at
the level of secondary
container that was not included
in stability studies.Return
19. Lets imagine if something goes
wrong. Your product is
distributed all across Pakistan
even to some other countries.
How would you assure that
your recall system will work?
Recall
Qualification
21. What it means?
How much it is important?
What are the obligations?
Recall
22. Particles are reported visible in
multiple lots of your particular
injections
Multiple reports from nurses,
pharmacists & physicians
How would you proceed. Write
step by step
Complaint
23. Cracking of vials is reported in
some units of different lots of
your multiple injections
Multiple reports from nurses,
pharmacists & physicians
How would you proceed. Write
step by step
Complaint
24. Meningitis is observed in a
patient who was healthy and
was administered single IV
dose of your product
alendronate sodium a day
before.
How would you proceed. Write
step by step
Complaint
25. A sharp decrease in potency
observed at 12 month of life
during annual stability study.
The shelf life is 3 years.
How would you proceed. Write
step by step
Observation
26. Pharmacy reported that your
strips lack of two tablets and
instead of 10 tablets, strip
contain 8 tablets.
How would you proceed.
Complaint
27. Pharmacy reported that your
strips of 28 tablets in which
first 4 tablets are supposed to
be placebo and required to be
administered in first 4 days are
wrongly packed in the strip as
last 4 tablets, that give sound of
consumption for last 4 days.
How would you proceed.Complaint
28. People are dying with
unknown drug in a particular
hospital. It is confirmed that
your drug was also included in
the prescription of died
patients.
How would you respond?
News
29. Severe anaphylactic shock is
reported after administration of
your IV Cephalosporin drug in
3 different healthcare facilities.
Same facilities experienced
similar anaphylactic shock with
other brands of similar
generics.
How would you respond?Complaint
30. An unpleasant smell is
experienced by the consumer
upon opening of glass bottles
containing your drug. It is your
old drug and this complaint has
newly emerged.
How would you respond?
Complaint
31. Recall of another company was
initiated due to potential
contamination of penicillin
with material used for their
formulation. You do purchase
same material of same
manufacturing site through
another vendor.
How would you respond?Complaint
32. A product has two strengths
25 mg & 125 mg.
Label mix-up ended
125 mg with 25 mg claim.
How would you respond?
Complaint
Higher strength than claim
33. A product has two strengths
25 mg & 125 mg.
Label mix-up ended
25 mg with 125 mg claim.
How would you respond?
Complaint
Lower strength than claim
34. You are certainly aware that your
API supplier is issued an import
alert notice from any country
because of fraudulent data and
integrity issues. You have
materials in your stock from that
supplier and a number of batches
manufactured from that affected
material are in market.
How would you respond?Surprise
35. Natural disaster at a particular
geographical location. Breakdown
of electricity occurred where your
drug was stored. Environment
experienced cool shocks of -20 ℃
for several days. Your product
was demonstrated stable at 2 to
8℃.
How would you respond?
Salvaged
36. Natural disaster at a particular
geographical location. Breakdown
of electricity occurred where your
drug was stored. Environment
experienced heat shocks of +40 ℃
for several days. Your product
was demonstrated stable at 15 to
25℃.
How would you respond?
Salvaged
37. You manufactured 3 million liter
syrup in 3 years of 3 year shelf life.
You found deterioration of API in
regular study at 6 months. You
investigated and took 6 months to
establish it. Once you established, 2
million liter was in market. You
stopped manufacturing and started
recall. Less than 2 liter was recalled
in next 6 months.
Please comment what went wrong?Efficiency
38. Your drug product in market was
claimed to be in child resistant
container. It was reported that some
children are able to open it. you
checked and found something is
wrong with your container that was
used in a particular year. However,
same is not verified from retention
samples.
What should be the recall class?
Claim
39. A particular batch of your product
is counterfeited. Public health is a
shared responsibility of government
and manufacturer.
What is your responsibility?
Counterfeit
40. Fast release was reported by the
Government laboratory for your
product or for your drug claimed to
be based on advance delivery
system.
How will you respond, if it is
patches?
How will you respond, if it is oral
tablet?
Release Profile
43. A
B
D
E
C
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer
45. B
C
E
A
D
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer
47. C
D
A
B
E
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer
49. D
E
B
C
A
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer
51. E
A
C
D
B
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer