- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.67
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.165- 483 observations- Warning Letters- Other Guidance- How to avoid observations
Subpart I--Laboratory ControlsSec. 211.165 Testing and release for distribution. 21 CFR 211.165(a), (b) , (c) , (d) , (e) &(f)
Top 20 observation series 2: 21 CFR 211.22Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.22 (a) 21 CFR 211.22 (b) 21 CFR 211.22 (c) 21 CFR 211.22 (d) - 483 observations- Warning Letters- Other Guidance- How to avoid observations
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Top 20 observation series # 5 21 CFR 211.100Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.100
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
Top 20 observation series # 6 21 CFR 211.165 - Testing and release for dist...Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.165- 483 observations- Warning Letters- Other Guidance- How to avoid observations
Subpart I--Laboratory ControlsSec. 211.165 Testing and release for distribution. 21 CFR 211.165(a), (b) , (c) , (d) , (e) &(f)
Top 20 observation series 2: 21 CFR 211.22Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.22 (a) 21 CFR 211.22 (b) 21 CFR 211.22 (c) 21 CFR 211.22 (d) - 483 observations- Warning Letters- Other Guidance- How to avoid observations
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Top 20 observation series # 5 21 CFR 211.100Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.100
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
Top 20 observation series # 3 21 CFR 211.192Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.192
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Batch Record Review - Investigations
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
Top 20 observation series 1 21 CFR 211.160Sathish Vemula
The module Consult Yourself.... “Know Regulation - No Observation” deals with most common (top 20) basic CFR regulations having frequent violations and previous observations for better understanding.
#1 dealing with Regulation "21 CFR 211.160 " enclosed with the following content
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 211.160 General requirements.
21 CFR 211.160 (a)
21 CFR 211.160 (b)
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Message from Experts
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016Sathish Vemula
To recap the previous month's pharma highlights, Monthly magazine Volume 22 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
Warning Letters
- Warning letter: Sun Pharmaceutical Industries Ltd.
- Warning letter: One Way Drug, LLC
- Warning letter: Thomas S. Tooma, M.D.
EU Non Compliance Report
- Non Compliance Report: Iason Italia SRL, Italy
- Non Compliance Report: AstraZeneca Pharma India Ltd., India
Regulations of the Month
- Sec. 211.48 Plumbing (b)
- Sec. 211.50 Sewage and refuse
- Sec. 211.52 Washing and toilet facilities
- Sec. 211.56 Sanitation (a)
Top 20 observation series # 3 21 CFR 211.192Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.192
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Batch Record Review - Investigations
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
Top 20 observation series 1 21 CFR 211.160Sathish Vemula
The module Consult Yourself.... “Know Regulation - No Observation” deals with most common (top 20) basic CFR regulations having frequent violations and previous observations for better understanding.
#1 dealing with Regulation "21 CFR 211.160 " enclosed with the following content
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 211.160 General requirements.
21 CFR 211.160 (a)
21 CFR 211.160 (b)
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Message from Experts
Pharma Uptoday Monthly Magazine Volume 22; Issue Jan 2016Sathish Vemula
To recap the previous month's pharma highlights, Monthly magazine Volume 22 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
Warning Letters
- Warning letter: Sun Pharmaceutical Industries Ltd.
- Warning letter: One Way Drug, LLC
- Warning letter: Thomas S. Tooma, M.D.
EU Non Compliance Report
- Non Compliance Report: Iason Italia SRL, Italy
- Non Compliance Report: AstraZeneca Pharma India Ltd., India
Regulations of the Month
- Sec. 211.48 Plumbing (b)
- Sec. 211.50 Sewage and refuse
- Sec. 211.52 Washing and toilet facilities
- Sec. 211.56 Sanitation (a)
To recap the previous month's pharma highlights to members, Monthly magazine Volume 20 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
- Pernix Receives Form 483 for cGMP Violations
- FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years
- Galena Hit With 10-Item Form 483 Over Unresolved Issues
Warning Letters
- Warning letter: Unimark Remedies Ltd., Mumbai, India
- Warning letter: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Health Canada Non Compliance Report
- Non Compliance Report: Unilever Canada Inc.
EMA Non-Compliance Report
- GlaxoSmithKline (Tianjin) Company Limited (Teda), China
- CARGILL FRANCE
Regulations of the Month
- Sec. 211.42 Design and construction features (c)(5) to (c)(10)
- Sec. 211.44 Lighting
To recap the previous month's pharma highlights, Monthly magazine Volume 19 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations (Millers of Wyckoff, Inc., NJ, - Producer of Sterile Drugs & InvaGen Pharmaceuticals, Inc., NY
Warning Letters (Pan Drugs Ltd., India & Jaychem Industries Ltd, New Zealand)
Health Canada Non Compliance Report (MS Pharma, Inc, Canada.)
WHO Notice of Concern (NOC)Report (Svizera Labs Private Limited, India)
Article of the Month - Warning Signs of a Weak Quality Culture
Regulations of the Month - Sec. 211.42 Design and construction features (c)(1) to (c)(4)
Pharma Uptoday Monthly Magazine Volume 21; Issue Dec 2015Sathish Vemula
News Uptoday
New Guidance
Audit Findings
- Diabetes Corporation of America
- Pine Pharmaceuticals
Warning Letters
- Warning letter: American Family Pharmacy
- Warning letter: Dr. Reddy's Laboratories Limited
- Warning letter: Sandoz Private Limited
Article of the Month
- Data Integrity Checklist related to Electronic Records and Electronic Signatures.
Regulations of the Month
- Sec. 211.46 Ventilation, air filtration, air heating and cooling
- Sec. 211.48 Plumbing
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
Celebrating Successful completion of one year
"Happy anniversary… Pharma Uptoday"
Thanks a lot to all members & Viewers.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 4 has been released with
News Uptoday
New Guidelines
Audit Findings
Regulation of the Month
Top 20 observation series # 7 21 CFR 211.42 (Subpart C-Buildings and Facili...Sathish Vemula
- US FDA inspectional observations - 2014- List of “Top 20 – CFR parts to know”- Sec. 21 CFR 211.42- 483 observations- Warning Letters- Other Guidance- How to avoid observations related to 21 CFR 211.42 ?
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 5 has been released with
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of Downing Labs
- 483 of Impax Laboratories
FDA Recall letter observations
- Unique Pharmaceuticals Ltd
Warning Letters
- Pharmacy Creations, NJ
- Trifarma S.p.A., Italy
- Zhejiang Jiuzhou Pharmaceutical Co., China
EMA Non-Compliance Reports
- WOCKHARDT LIMITED, India
- SIMS Società Italiana Medicinali Scandicci srl, Italy
- SCM PHARMA LIMITED, UK
Regulations of the Month
§ 211.167 Special testing requirements
§ 211.170 Reserve Samples
§ 211.176 Penicillin contamination
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
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/
In the month of February 2014 US Food and Drug Administration Commissioner Margaret Hamburg visited India to discuss issues of drug quality with her counterparts in the Indian Government. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.There were comments made about the US and Indian GMP Standards. Drug Regulations has now compared the GMP standards of US and India. The comparison is given in the presentation here.
FDA Form 483 (Inspectional Observations) - Top Violations 2013Marc Sanchez
FDA Attorney Marc Sanchez discusses the Top FDA Form 483 (Inspectional Observations) from fiscal year 2013. The top observations provide a foundation for preparing for a pre-inspection, for-cause inspection, or routine surveillance inspection.
Getting to know 21 cfr 210 and 211 by micah thomas with speaker notes update ...Micah Thomas
Introduction to Title 21, Code of Federal Regulations, Part 210 & 211, Good Manufacturing Practices, Historic timeline of pharmaceutical regulations and industry practices
This is a presentation I gave to Medical Alley in 2016 as an introductory to pharmaceutical regulations, to a largely medical device audience. I have updated it as of April 2021 to include current links and information. It may be helpful for training purposes. Please feel free to download it here or contact me at LinkedIn 'Micah Thomas' for a free PowerPoint copy with speaker notes.
https://www.linkedin.com/in/micahthomas/
Module 1: Introduction to FDA and Quality System RegulationsQAConsulting
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Drug Regulations is a Not for Profit Organizations which provides free online resources for the Pharmaceutical Professional. This presentation is part D of series of presentations which addresses the current Good Manufacturing Requirements as per the US FDA. This presentation addresses : Equipment
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào chế không vô trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- Polydrug Laboratories PVT. LTD., Ambernath, Maharashtra, India
- ZHUHAI UNITED LABORATORIES CO., LTD, China
Health Canada Non Compliance Report
- Pharmax Limited, Ontario Canada.
Warning Letters
- VUAB Pharma a.s., Czech Republic
- Attix Pharmaceuticals, Canada
Regulations of the Month
- Sec. 211.22 Responsibilities of quality control unit
Pharma Uptoday Monthly Magazine Volume 12; Issue Mar 2015Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 12 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- India's Lupin says FDA raises concerns over plant at Pithampur
Warning Letters
- Micro Labs Limited, Bangalore
- Apotex Research Private Limited
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Cantrell Drug Company
- Warning Letters on Data Integrity: What does the FDA expect from Third Party Auditors and Consultants?
Regulations of the Month
- § 211.194 Laboratory records (a)(5)(6)(7)(8) & (b)
3 News Uptoday
35 New Guidance
42 Audit Findings
483 Observations
- Top Drug 483 Observations
46 EMA Non-Compliance Reports
- Wockhardt Limited, Aurangabad
- AGEPHA, Austria
- North China Pharmaceutical Group Semisyntech Co., Ltd, China
48 Regulations of the Month
- § 211.188 Batch production and control records
- § 211.192 Production record review
- § 211.194 Laboratory records.
To recap the previous month's (Dec- 2014) pharma highlights to Pharma Uptoday members, Monthly magazine Volume 10 has been released with the following content.
3 News Uptoday
24 New Guidance
34 Audit Findings
483 Observations
- Teva Parenteral Medicines Inc (Jul-2009)
- Hovione API facility in Portugal
- Impax Hit With Another FDA 483
38 Warning Letters
- Novacyl Wuxi Pharmaceutical Co., Ltd.
40 EMA Non-Compliance Reports
- Medreich Limited – Unit V
- Sri Krishna Pharmaceuticals Ltd., Hyderabad, India
43 Regulations of the Month
§ 211.188 Batch production and control records
3 News Uptoday
22 New Guidance
28 Audit Findings
483 Observations
- Caraco Pharmaceutical Laboratories
- Hospira Inc
- Novartis Consumer Health
- McNeil Consumer Healthcare
Warning Letters
- Hikma Farmaceutica, (Portugal) S.A.
- Cadila Pharmaceuticals Limited
- Sharp Global Limited
- Wells Pharmacy Network LLC
EMA Non-Compliance Reports
- Taishan City Chemical Pharmaceutical Co. Ltd., China
- Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., China
- MANUEL RIESGO S.A., Spain
- Ranbaxy Laboratories Limited, Dewas, India
36 Regulations of the Month
§ 211.186 Master production and control records
§ 211.188 Batch production and control records
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma group, Monthly magazine Volume 7 has been released with
3 News Uptoday
30 New Guidance and New MAPP Release
37 Audit Findings
483 Observations
- 483 of Alexander Infusion
Warning Letters
- John W Hollis Inc.
EMA Non-Compliance Reports
- Hebei Dongfeng Pharmaceutical Co., Ltd, China
- I.C.I. International Chemical Industry, Italy
41 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
2. - 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.67
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
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Contents
3. Total Inspectional Observations
Center Name 483s Issued
Foods 2476
Devices 972
Drugs 645
Veterinary Medicine 337
Bioresearch Monitoring 297
Biologics 146
Human Tissue for Transplantation 115
Parts 1240 and 1250 70
Radiological Health 16
Sum Product Area 483s from System* 5074
Actual Total in System 483s** 4943
Number of 483s Issued from the System*
Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM
4. Inspectional Observations - Drugs
Summary Count (Number)
Total 483’s issued for Drugs center in 2014 645
Total number of observations issued for Drugs center in 2014 2997
Total number of observations related to cGMP (21 CFR part 211) violations 2835
Total number of top 10 CFR part 211 violation 1653 (58%)
Total number of top 15 CFR part 211 violation 2110 (74%)
Total number of top 20 CFR part 211 violation 2398 (85%)
Number of CFR part 211 parts violated 54
7. List of “Top 20 – CFR parts to know”
S.No. CFR Frequency %
1 21 CFR 211.160 235 8.3
2 21 CFR 211.22 218 7.7
3 21 CFR 211.192 209 7.4
4 21 CFR 211.67 184 6.5
5 21 CFR 211.100 167 5.9
6 21 CFR 211.165 143 5.0
7 21 CFR 211.42 143 5.0
8 21 CFR 211.113 128 4.5
9 21 CFR 211.166 115 4.1
10 21 CFR 211.25 111 3.9
11 21 CFR 211.68 99 3.5
12 21 CFR 211.198 95 3.4
13 21 CFR 211.84 91 3.2
14 21 CFR 211.110 89 3.1
15 21 CFR 211.194 83 2.9
16 21 CFR 211.188 74 2.6
17 21 CFR 211.180 72 2.5
18 21 CFR 211.28 53 1.9
19 21 CFR 211.186 48 1.7
20 21 CFR 211.63 41 1.4
Total 2398 85
• The top 10 cGMP violations (21
CFR part 211 observations)
comprises a huge percentage
(58% i.e. 1653 number of
observations).
• The top 20 cGMP violations (21
CFR part 211 observations)
comprises a high percentage
(85% i.e. 2398 number of
observations).
• If the top 20 violations are
eliminated, 85 % of the
observations can be reduced.
8. Subpart I--Laboratory Controls
Sec. 211.160 General requirements.
21 CFR 211.160 (a)
21 CFR 211.160 (b)
21 CFR 211.160 can be accessed from the link:
http://www.slideshare.net/skvemula/top-20-observation-
series-1-21-cfr-211160
pharmauptoday@gmail.com
21 CFR 211.160
9. Subpart B--Organization and Personnel
Sec. 211.22 Responsibilities of quality control unit.
21 CFR 211.22 (a)
21 CFR 211.22 (b)
21 CFR 211.22 (c)
21 CFR 211.22 (d) can be accessed from the link:
http://www.slideshare.net/skvemula/top-20-observation-
series-2-21-cfr-21122
pharmauptoday@gmail.com
21 CFR 211.22
10. Subpart J--Records and Reports
Sec. 211.192 Production record review.
21 CFR 211.192 can be accessed from the link:
http://www.slideshare.net/skvemula/top-20-observation-
series-3-21-cfr-211192
pharmauptoday@gmail.com
21 CFR 211.192
14. CFR part 211 Regulation - 21 CFR 211.67(a)
Subpart D--Equipment
Sec. 211.67 Equipment cleaning and maintenance.
(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the
nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent
malfunctions or contamination that would alter the safety, identity, strength, quality, or
purity of the drug product beyond the official or other established requirements.
16. 483 citations related to 21 CFR 211.67(a)
Cite Id
Reference
Number
Short Description Long Description
Frequency
2014 2013
1213 21 CFR 211.67(a)
Cleaning / Sanitizing /
Maintenance
Equipment and utensils are not [cleaned] [maintained]
[sanitized] at appropriate intervals to prevent
[malfunctions] [contamination] that would alter the
safety, identity, strength, quality or purity of the drug
product. Specifically, ***
63 71
18. CFR part 211 Regulation - 21 CFR 211.67(b)
Subpart D--Equipment
Sec. 211.67 Equipment cleaning and maintenance.
(b) Written procedures shall be established and followed for cleaning and maintenance of
equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug
product. These procedures shall include, but are not necessarily limited to, the following:
(1) Assignment of responsibility for cleaning and maintaining equipment;
(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;
(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance
operations, and the methods of disassembling and reassembling equipment as necessary to assure proper
cleaning and maintenance;
(4) Removal or obliteration of previous batch identification;
(5) Protection of clean equipment from contamination prior to use;
(6) Inspection of equipment for cleanliness immediately before use.
20. 483 citations related to 21 CFR 211.67(b)
Cite Id Reference Number Short Description Long Description
Frequency
2014 2013
1215 21 CFR 211.67(b)
Written procedures not
established/followed
Written procedures are not [established] [followed] for the cleaning and maintenance of equipment,
including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically, ***
72 77
4303 21 CFR 211.67 b)
Written procedures fail to
include
Written procedures for cleaning and maintenance fail to include [assignment of responsibility]
[maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and
materials used] [description in sufficient detail of the methods of disassembling and reassembling
equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or
obliteration of previous batch identification] [instructions for protection of clean equipment from
contamination prior to use] [parameters relevant to the operation]. Specifically, ***
23 26
1219
21 CFR
211.67(b)(2)
Cleaning SOPs/schedules
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and
cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
1 1
1220
21 CFR
211.67(b)(3)
Cleaning
SOPs/instructions
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of
the methods, equipment, and materials used in the cleaning and maintenance operation, and the
methods of disassembly and reassembling equipment as necessary to assure proper cleaning and
maintenance. Specifically, ***
3 1
1222
21 CFR
211.67(b)(4)
Cleaning SOPs/equipment
identification
Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or
obliteration of the previous batch identification. Specifically, ***
1 1
1223
21 CFR
211.67(b)(5)
Cleaning SOPs/equipment
protection
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of
clean equipment from contamination prior to use. Specifically, ***
2 0
1224
21 CFR
211.67(b)(6)
Cleaning SOP/inspection
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the
equipment for cleanliness immediately before use. Specifically, ***
1 1
21. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Andrx Pharmaceuticals Inc (04/2006)
22. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Andrx Pharmaceuticals Inc (04/2006)
23. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Andrx Pharmaceuticals Inc (04/2006)
24. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Andrx Pharmaceuticals Inc (04/2006)
25. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Teva Parenteral Medicines Inc (07/2009)
26. 483 citations related to 21 CFR 211.67(b)
Ref: 483 of Teva Parenteral Medicines Inc (07/2009)
28. Warning letter observations -2014 - 21 CFR 211.67(b)
Failure to adequately complete and follow written procedures for cleaning equipment and its
release for use in API manufacture, and to maintain adequate records of major equipment
usage.
• Your firm failed to ensure that employees adequately cleaned (b)(4) after
use. Your (b)(4) equipment cleaning standard operating procedures (SOP-HE 063-02 - instruction
4.2.2.1, SOP-HE 064-02 – instruction 4.3.4.3, and SOP-HE 055-02 – instruction 4.2.1.1), require
that employees visually inspect equipment after the cleaning process. Our inspection found (b)(4) in
the manufacturing workshop for (b)(4) with various levels of contamination and foreign objects
inside, including what looked like the remains of a pen in one of the (b)(4). Your employees had
labeled this equipment as clean. These (b)(4) are used for the manufacture of multiple APIs.
• In addition, your firm’s production system did not maintain equipment logs or other documents that
adequately record manufacturing operations performed on individual pieces of equipment.
• We note that your production operation supervisors and Quality Unit (QU) failed to detect and
correct these deficient cleaning practices.
Ref: WL: Tianjin Zhongan Pharmaceutical Co., Ltd. 6/10/14 (320-14-09)
29. Warning letter observations -2013 - 21 CFR 211.67(b)
Ref: WL: Ameriderm Laboratories, Ltd. 12/2/13 (14-NWJ-02)
Your firm failed to establish and follow adequate written procedures for
cleaning and maintenance of equipment (21 CFR 211.67(b)).
For example, the cleaning procedures described in Chapter 2-SOP-5 Cleaning of
Batching Vessels lack detailed instructions for the cleaning and sanitization of non-
dedicated equipment, including mixing kettles and tanks, used to manufacture your
OTC drug products. There is no assurance that the cleaning and sanitization
methods described in your cleaning validation documents are adequate.
In addition, your firm does not maintain individual equipment logs for non-dedicated
equipment, including mixing kettles and tanks, in order to document equipment
cleaning, maintenance, and use.
30. Warning letter observations -2013 - 21 CFR 211.67(b)
Ref: WL: P.A. Benjamin Manufacturing Co., Ltd. 1/29/13 (WL: 320-13-07)
Your firm failed to establish and follow adequate written procedures for
cleaning and maintenance of equipment (21 CFR 211.67(b)).
For example, your firm failed to validate a cleaning method used for the multi-
product manufacturing equipment and utensils. Your firm has no assurance that your
current, manual cleaning methods are effective in removing residues of drug
products and detergents from the manufacturing equipment and utensils.
Additionally, your firm failed to validate the “(b)(4)” device used to
detect (b)(4) traces on the equipment surfaces after cleaning. Finally, your firm failed
to implement procedures on the proper use of the device.
31. Warning letter observations -2013 - 21 CFR 211.67(b)
Ref: WL: CMI Cosmetic Manufacturers Inc. 4/25/13 (WL: 320-13-13)
Your firm failed to establish and follow adequate written procedures for
cleaning and maintenance of equipment (21 CFR 211.67(b)).
For example, your firm has failed to evaluate the effectiveness of your cleaning
procedures. You do not have data to show that your equipment cleaning procedure
is adequate to prevent cross-contamination.
Specifically, your firm has not conducted cleaning validation, cleaning verification, or
swab recovery studies for multi-use equipment used in the production of your OTC
drug products.
33. CFR part 211 Regulation - 21 CFR 211.67(c)
Subpart D--Equipment
Sec. 211.67 Equipment cleaning and maintenance.
(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified
in 211.180 and 211.182.
35. 483 citations related to 21 CFR 211.67(c)
Cite Id
Reference
Number
Short Description Long Description
Frequency
2014 2013
1227
21 CFR
211.67(c)
Cleaning/maintenance
records not kept
Records are not kept for the [maintenance] [cleaning]
[sanitizing] [inspection] of equipment. Specifically, ***
18 12
36. 483 citations related to 21 CFR 211.67(c)
Ref: 483 of Amylin Pharmaceutical Inc (12/2009)
37. Warning letter observations -2014 - 21 CFR 211.67
Failure to document manufacturing operations at the time they are performed.
• When reviewing the entries in your (b)(4) use, cleaning, and maintenance logbook for the
days immediately prior to the inspection, our investigator found missing entries. Your
operators stated that lines were left blank to later add information about cleaning events
that may have occurred during a previous shift.
• During the inspection, our investigator found other similar instances of missing data or
belated data entry in your manufacturing records. These practices are not consistent with
CGMP. Operators acknowledged that there is no system in place to report these lapses in
the documentation system; documentation errors of this type did not require deviation
investigations or notification to the Quality Unit.
Ref: WL: Zhejiang Jiuzhou Pharmaceutical Co., Ltd. 7/9/14 (320-14-12)
38. Summary of Observations
• Inadequate equipment cleaning and validation protocols
• Cleaning methods for common equipment not validated
• Inadequate sampling and testing of equipment surfaces
• No record to document alarms with the cleaning equipment
• CIP record sheets that document the CIP of the manufacturing equipment are not reviewed by Production
or Quality Assurance Staff.
• Residue limits for potential contaminants not established
• Specificity and sensitivity of analytical methods not established
• No testing for residues of solvents used in API production
• The CIP validation didn’t include studies to determine or evaluate what are the most difficult (“Hot Spot”)
locations to clean.
47. EU Non-Compliance Reports
Firm Name Nature of non-compliance
Wockhardt Limited,
Aurangabad; Jan 2015
A major deficiency was cited with regards to equipment and facility, maintenance, design
and qualification. Examples included, inappropriate pressure differentials that were not in
line with the original design but had not been changed using change control, cleaning
validation that was not sufficiently robust to confirm cleaning practices and maintenance
issues, such as the failure to spark test glass lined reactor vessels for integrity especially
following maintenance.
MANUEL RIESGO S.A.,
Spain; Nov 2014
Utensils are not cleaned and stored to prevent contamination.
Taishan City Chemical
Pharmaceutical Co.
Ltd., China; Nov 2014
Multiple risks of contamination identified in the production areas of Ciclosporin (e.g. no
protection of clean equipment outlets, equipment under status “to be used for production”
stored dirty for several months, open parts of the final steps exposed in dirty
surroundings);
VETPROM AD,
Bulgaria; Aug 2014
The procedure for cleaning validation is ineffective and does not include all medicines
(human and animal medicinal use);
49. Health Canada – GMP
• Examples of observations from frequently cited sections of the Food and Drug
Regulations - Good Manufacturing Practices Inspections
57. Basics
Clean(liness) (adj.)
• visually clean - absence of materials which would
adulterate a product when inspected with the eyes
• detectably clean - absence of materials which would
adulterate a product down to the level of detection
• chemically clean - absence of all chemicals which would
adulterate a product.
Cleaning validation
• Documented evidence to establish that cleaning
procedures are removing residues to predetermined levels
of acceptability, taking into consideration factors such as
batch size, dosing, toxicology and equipment size.
58. Cleaning Documentation
• The cleaning validation must document the efficiency of a cleaning procedure
• The cleaning procedure must be reliable with regard to removal of contamination (e.g.
products, cleaning agents, microorganisms) to a predetermined acceptable level
• Procedures for cleaning of areas in product contact must be validated (with consideration to areas out
of product contact).
• The intervals between use and cleaning of equipment as well as between cleaning and reuse must be
validated.
59. Recordings
• Preceding product
• ”Batch to batch” cleaning or ”product to product” cleaning
• The cleaning documentation for equipment which is considered to be critical for the
product
• Sampling of equipment which is considered critical for the product
• Applied cleaning agents and concentrations (batch no.)
• Time of cleaning – date of performance and signature
• Observations during inspection of equipment prior to production
60. Equipment Cleaning
• Preparation and storage of cleaning solutions, maintenance of cleaning equipment, such as
mops, buck, etc., and procedures used for cleaning.
• review the regulatory requirements for establishing a cleaning program.
• Discuss personnel qualifications, written procedures, selection of cleaning agents, and
recordkeeping.
• Determine if the procedures are being followed, and if they specify the cleaning agents and the
preparation of those cleaning agents.
• Ensure that the cleaning agents, their concentration, and the procedure for use are consistent with
those that have been used in the cleaning validation.
• Review the written procedures for equipment cleaning. Ensure that the purpose of the cleaning is
consistent with the agent chosen for use. For example, if the objective of the cleaning is to sanitize
a piece of equipment, ensure that the cleaning agent chosen is designed to accomplish the desired
sanitization by reviewing the technical literature available from the supplier.
61. Approach
The following considerations are proposed as part of a systematic approach to determine the most difficult-to-
clean sampling locations in manufacturing equipment:
• Equipment technical analysis. The type of surface, interfacial effects, and shadowed areas should be
considered. Materials of construction (MOC) and geometrical configurations, type of processing (wet or
dry), and problematic hard-to-clean areas of the equipment are noted. For example, stainless steel is
generally harder to clean than glass or Teflon. Additionally, for a specific MOC, the smoothness of the surface
can significantly affect its cleanability.
• Observation of equipment after processing. The equipment is observed after processing typical
pharmaceutical products. Areas of excessive process residue accumulation are noted.
• Equipment disassembly review. The equipment is observed after disassembly. Product contact areas that
are the most difficult to clean are noted. Equipment components that are disassembled for cleaning and
subsequent evaluation pose a much lower risk than components that are part of the fixed equipment assembly
and are cleaned in place. Accessibility of components on the fixed equipment assembly is noted.
• Cleaning procedure review. The cleaning procedure for the equipment is reviewed. Ability to visually
observe equipment and components is noted. Parts and equipment locations previously identified as difficult
to clean may not be difficult to clean after equipment disassembly.
• Operator interviews. Discussions with operators experienced with cleaning the equipment of interest are
utilized to determine difficult-to-clean locations. Their recommendations of difficult-to-clean areas of the
equipment based on actual experience are noted.
62. Considerations ….
• Cleaning procedures should be sufficiently detailed to remove the possibility of any inconsistencies during
the cleaning process. Following parameters are to be considered during cleaning procedures.
A. Equipment
Parameters to be
evaluated
• Identification of the
equipment to be
cleaned
• 'Difficult to clean' areas
• Property of materials
• Ease of disassembly
• Mobility
B. Residues to be
cleaned
• Cleaning limits
• Solubility of the
residues
• Length of campaigns
C. Cleaning agent
parameters to be
evaluated
• Preferable materials
that are normally used
in the process
• Detergents available
(as a general
guide, minimal use of
detergents
recommended unless
absolutely required)
• Solubility properties
• Environmental
considerations
• Health and safety
considerations
D. Cleaning techniques
to be evaluated
• Manual cleaning
• CIP (Clean-in-place)
• COP (Clean-out-of-
place)
• Semi automatic
procedures
• Automatic procedures
• Time considerations
• Number of cleaning
cycles
63. Considerations ….
• Automated Cleaning
Vs Manual Cleaning
• Clean-In-Place (CIP)
Vs Clean-Out-of-
Place (COP)
Cleaning
Program
Criteria
• Dedicated Vs Non-
Dedicated Manufacturing
Equipment
• Dedicated Vs Non-
Dedicated Cleaning
Equipment
• Non-Product Contact Vs
Product Contact
Surfaces
• Non-Critical Site Vs
Critical Site
• Minor Equipment Vs
Major Equipment
Equipment
Characteristics /
Materials of
Construction
• Low Risk Vs High
Risk Drugs
• Highly Characterized
Vs Poorly
Characterized
• Non-Sterile Vs
Sterile
Product
Attributes
• Solids Vs Liquids
• Soluble (Active or
Excipient) Vs
Insoluble (Active or
Excipient)
Formulation
Attributes
• Single Product
Facility Vs Multiple
Product Facility
• Campaign
Production Vs
Batch Production
• Simple Equipment
Train Vs Complex
Equipment Train
Operational
Issues
64. Training
Training practices will vary from one company to another but operator training may be enhanced by
some of the following suggestions:
- Clearly written, understandable and sufficiently detailed SOPs.
- Use of checklists to determine that all operations are carried out in the proper sequence and are
documented.
- Periodic monitoring of cleaning processes to ensure proper training of operators and continued
compliance with SOPs.
- Dedicated or assigned cleaning personnel.
- Feedback from operators to modify procedures.
- Use of video to demonstrate proper cleaning operations and techniques.
• Overall the operators should understand the process of cleaning and the operation of the
equipment they are cleaning. In addition the operators should be aware of the cleaning process
impact on the quality of the next product manufactured in the same equipment.
68. pharmauptoday@gmail.com
Thank You
The module Consult Yourself.... “Know Regulation - No Observation” deals with most common (top 20)
basic CFR regulations having frequent violations and previous observations for better understanding.
The module will be continued with # 5 21 CFR 211.100
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