10 South Colonnade, Canary Wharf, London, E14 4PU  Employees: 1,500  Annual budget: £100 million  Website: www.gov.uk/mhra  Parent organization: Department of Health and Social Care  Awards: None  Mission: To ensure medicines and medical devices work and are acceptably safe.  Jurisdiction: United Kingdom  Key people: Dr. June Raine, Chief Executive  Customer service: 020 3080 6000  Email: info@mhra.gov.uk

2. Presentation on Pharmaceuticals
sector In bangladesh
Course Title: English For Pharmacy
Course No.: 115
Ciprocin®
 Syed Sakibul Islam
 Zannatul Ferdosi
 MD. Ashraful Islam Ashik
 Raka Tasmira
 Mukul ChandraSarkar
 Mahfuza Akter
 MD.Rabius Sany

3. Student ID:
161211003

5. Background/History of Pharmacy
 The history of pharmacy as an independent science
dates back to the first third of the 19th century.

6. The evaluation of the profession of pharmacy
can be divided into five historical periods:
 ANCIENT ERA-The beginning of time to AD 1600
 EMPIRIC ERA-1600-1940
 INDUSTRIALIZATION ERA-1940-1970
 PATIENT CARE ERA-1970-present
 BIOTECHNOLOGY AND GENETIC ENGINEERING
ERA-The new horizon

7. ANCIENT ERA
 From the beginning of time to 1600 AD
 Used leaves, mud, and cool water to stop bleeding and
heal wounds
 Dry clay was used to sprint broken bones
 They copied the animal behavior
 Began to practice healing on clay tablets 2600 B.C.
 Also kept document. Such as-“Ebers Papyrus” written
by George Ebers around 1500 B.C.
 Hippocrates-The Father of Medicine

8. ANCIENT ERA

9. EMPIRIC ERA
 The Pharmacopeia became a regulatory tool for
pharmacists.
 Benjamin Franklin started the first hospital in 1751.
It had a pharmacy and the first hospital pharmacist
was Jonathan Roberts.
 1821 The Philadelphia College of Pharmacy was
founded.
 William Proctor-The father of American
Pharmacy. He devoted his time and attention to the
advancement of pharmacy. He owned an apothecary
shop.

10. INDUSTRIALIZATION ERA
 The development of manufacturing pharmacy
began. Rapid mass production of medicines followed.
 Standardization, biologically prepared products,
complex chemical synthesis, and increased use of
parenteral medications were all part of this period.

11. THE PATIENT CARE ERA
 The beginning of this era concentrated on
research to develop new medicines.
 New drugs were developed. Pharmacists began to
take a more hands on role in dispensing
medications and patient education.

12. BIOTECHNOLOGY AND GENETIC
ENGINEERING ERA
 DNA and Genetic Technology have been started.
 Gene therapy is being conducted. Many diseases are
linked to genetic defacts.
 Recombinent DNA Technology: Recombinent
DNA is a form of syntetic DNA that is engineered
through the combination of insertion of one or
more DNA strands combining DNA sequences that
would not normally occur together.

13. History of Pharmacy in
Bangladesh
 Department of Pharmacy started its journey in 1964.
 Prof Kamaluddin Ahmed was the first Chairman of the
Dept. of Pharmacy and Dept. of Biochemistry.
 Only 20 students, a few teachers and fewer physical
facilities, lecture rooms, labs andutilities.
 1964 to 1966, Both the Dept of Biochemistry and the
Dept of Pharmacy were virtually sharing the same class
rooms and labs.
 Same batch of teachers use to teach the pharmacy and
biochemistry under graduates.

14. History of Pharmacy in
Bangladesh
 Prof A. Jabbar became the chairman of the Dept. of
Pharmacy in 1966
 In 1969 the Dept first started its M Pharm Course for
thesis students, limited to 3 to 4 students.
 In 1st Feb’1969 a group of young talented teachers(
AKAC, SNK and BKD) joined the dept.
 Finally,
In 1970 the B.Pharm graduates got the chance to do
Pharm both in the thesis and non thesis groups

15. Present Status of Pharmacy in
Bangladesh
Local Market Condition
 About 30 companies export a significant quantity of
medicines to 107 countries including USA, UK, Canada,
France, Italy, Netherlands etc.
 More than 5600 Brands of medicines manufactured by
these local companies.
 Pharmaceutical exports from Bangladesh rose 15.65% year
to year.
 According to 2013 the local pharmaceutical market size of
Bangladesh was 1.3 Billion USD and the annual growth rate
was 8.12%. But in 2015 the market size is about 5.00 Billion
USD.

16. A Data Chart are given bellow-
Type of Drug
Manufacture
Number of
Manufacturing
Companies
Current Manufacturing
Status
Allopathic Drug
Manufacturers
199 Functional
Ayurvedic Drug
Manufacturers
172 Functional
Herbal Drug
Manufacturers
29 Functional
Homeopathic &
Biochemic Drug
Manufacturers
28 Functional

17. Educational Sectors
 Currently, there are 9 public universities and 23 private
universities in Bangladesh offering pharmacy
education.
 Universities that offer pharmacy education in
Bangladesh are –
Public Universities
Private Universities

18. Public Universities
 University of Dhaka
 University of Rajshahi
 Jahangirnagar University
 Khulna University
 University of Chittagong
 Noakhali Science & Technology University
 Jagannath University
 Bangabandhu Sheikh Mujibur Rahman Science and
Technology University
 Jessore University of Science & Technology

19. Private Universities
 Varendra University
 North South University
 BRAC University
 East West University
 Southeast University
 State University of Bangladesh
 Stamford University Bangladesh
 Dhaka International University
 University of Science and Technology Chittagong (USTC)
 The University of Asia Pacific Dhanmondi
 Gono Biswabiddyalay

20. Private Universities
 Southern University Bangladesh
 University of Development Alternative (UODA)
 International Islamic University Chittagong (IIUC)
 BGC Trust University of Bangladesh
 Bangladesh University
 Atish Dipankar University of Science and Technology
 Daffodil International University
 World University of Bangladesh
 Manarat International University
 Primeasia University
 ASA University
 Northern University

22. Scope of Pharmacy
 Career Scope for Pharmacy Professionals
 Production & Manufacturing
 Research & Development
 Analysis & Testing
 Marketing
 Hospital Pharmacy
 Community Pharmacy
 Opportunities
 Academics

23. Scope of Pharmacy
 Regulatory Affairs
 Self employment
 Documentation, Library Information Services
& Pharma. Journalism
 Consultancy

26. Drug & Medicine
Definition of Drug
A drug ia any substance other than food, that when inhaled, injected, smoked,
consumed, absorbed, via a patch on the skin or dissolved under the tongue causes a
physiological change in the body.
Definition of Medicine
Medicine is the science and practice of the diagnosis, treatment and prevention of
disease. The word medicine comes from a latin word “medicus” means “A Physician

27. Difference between Drug &
Medicine
Point Drug Medicine
Definition
Substances which act on
the body and are used for
the prevention, diagnosis
and treatment
Substances that have definite form
and therapeutic use for treatment.
Amount Drug doesn’t have any
definite form & dose.
Medicine has a definite form &
dose.
Potency Drugs are the active potent
compound.
Medicines are the administrative
form of drug
Compare All drugs are not medicines. All medicines are drugs.
Example Paracetamol, Renitidine. Napa (paracetamol) 500 mg tablet,
Neocoptin-R (Renitidine) 150 mg
tablet.

28. Ciprocin®
 Brand Name: Ciprocin 250 mg tablet.
 Generic Name : Ciprofloxacin
 4-Quinolone Antibiotics (Quinolone Antibiotics)
 Indication: Urinary tract infections, lower respiratory
tract infections, skin and soft tissue infections, bone
and joint infections, G.I. infections, uncomplicated
gonorrhoea

29. Ciprocin®
 Preparation: Ciprocin™ 250 : Box containing 50, .
Ciprocin™ 500 : Box containing 30 tablets, . Ciprocin™
750: Box containing 20 tablets, Ciprocin™ XR 1 gm : Box
containing 12 tablets, Ciprocin™ 250 Powder for
suspension: Box containing two bottles, one HDPE
bottle for active ingredient and another PET bottle for
diluent.

31. Ashik

32. Drug Discovery and Drug
Development
 It takes 10–15 years to develop a medicine or vaccine.
 The research-based pharmaceutical industry currently
spends over USD 135 billion on R&D per year.
 In 2011, 35 new pharmaceuticals were launched.
 In 2007–2011, the number of new chemical or biological
entities launched on the world market fell to 149 from 196 a
decade earlier.
 It costs an average of USD 1.38 billion to develop a single
drug.
Key Points Regarding Drug Discovery and Development:

33. Key Points Regarding Drug
Discovery and Development
 In 2011, out of 10, 5 leading global R&D firms were
pharmaceutical companies
 It will take an average of 12-13 years to reach a product
in the market since the first synthesis.
 The cost of researching and developing a new
chemical or biological entity was estimated at €1,172
million ($ 1,506 million in year 2011 dollars) in 2012
 On average, only one to two of every 10,000 substances
synthesized in laboratories will successfully pass all
stages of development required to become a
marketable medicine.

34. Some International Drug
Regulatory Authorities are:
 International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
 European Medicines Agency (EMEA)
 Therapeutic Goods Administration (Australia) (TGA)
 U.S. Food and Drug Administration (FDA)
 Medicines and Healthcare products Regulatory
Agency (MHRA)
 GMP(Good Manufacturing Practices)

37. Raka
Student ID:
1612110

38. Designation of pharmacist with
their recruit requirement
 CEO/MD/Derector: UG: B.Sc, B.Tech/B.E. , Postgraduate,
Doctorate.
 Associate Professor : Ph.D with minimum 5 years
teaching experiance on Assistant professor.
 Production Executive : B Pharm & M Pharm.
 Quality Control (QC) : B Pharm & M Pharm.
 Quality Assurance (QA) : B Pharm & M Pharm.
 Product Development (PD) : B Pharm.
 Training Executive : B Pharm & M Pharm.
 Lecturer : B Pharm & M Pharm.
 Lab Demonstrator : B Pharm.

39. Responsibilities of pharmacist
(Worldwide)
 Development of Brand Plans/ Marketing Strategy.
 Increase the Market share and Profitability
 Designing of Promotional campaign and Development
of required Promotional tools.
 Co-ordinating with the team of Product Executives.
 New Product Launching
 Conducting fresh training program for Medical
Promotion Officers.

40. Responsibilities of pharmacist
(Worldwide)
 Maintain liaison with the concern people of Drug
Administration, Drug Testing Laboratories for
regulatory formalities.
 Conduct monthly sales meeting at different regional
head quarters in order to ensure understanding of
marketing action plan.
 Meeting the key doctors over the country and
exchange ideas to obtain feedback on the movement of
products.
 Analyzing Internal Sales.
 Handling field forces queries.

41. Roles and Responsibility of
pharmacist towards the society
 The quality of medicines supplied to patients.
 Ensuring the supply of medicines is within the law.
 Ensuring the medicines prescribed to patients are
suitable.
 Advising patients about the side-effect of the
medicines, how to take them and answering patients'
questions.
 Supervise the production and preparation of
medicines.
Pharmacists are responsible for:

42. Pharmacists also:
 Supervise the medicines supply chain and ensure
pharmacy premises and systems are fit for purpose
 Advise other healthcare professionals about safe and
effective medicines use, and safe and secure supply of
medicines
 Respond to patients' symptoms and advise on
medicines for sale in pharmacies
 Provide services to patients, such as smoking
cessation, blood pressure measurement and
cholesterol management etc.

43. Pharmacy Council of Bangladesh
(PCB)
 The Pharmacy Council of Bangladesh (PCB) is an
Autonomous Organization under the Ministry of Health
and Family Welfare, Govt. of the People's Republic of
Bangladesh.
 It was established under the Pharmacy Ordinance,
Ordinance No. X111 of 1976.
 It provide scope for the graduate pharmacists.
 The council is the controlling authority of pharmacy
education and practice.
 Recently, 8 pharmacists are working in PCB with advanced
level of performance ensuring the highest standard of
quality.
 The Main objective of PCB is to regulate the practice of
Pharmacy through out Bangladesh.
HISTORY

44. Structure of Pharmacy Council of
Bangladesh (PCB)
 President secretary of ministry of health and
familly
 President of council
 Director general of health service
 Directorate of drug administration
 Dean faculty of pharmacy of Dhaka University
 Professor of medicine
 Professor of pharmacology of medicinal institute
 One qualified pharmacist

45. The pharmacy council performs the
following activities:
 Approve examinations in pharmacy for qualifying persons
for registration as pharmacists.
 Prescribe the subjects in which approve examinations shall
be held.
 Approve the course of study and practical training in
pharmacy for the purpose of admission.
 Prescribe the condition and procedure for admission of
candidates to and approved examination;
 Prescribe the equipments and facilities to be made
available to the students.

46. Student ID :
16121100

47. The pharmacy council performs the
following activities:
 To recognize degree or diploma in pharmacy for the
purpose of registration as pharmacist;
 Undertake inspections of institutions which conduct the
course of study in pharmacy.
 Prepare and maintain registers of pharmacists and
apprentices in pharmacy.
 To register pharmacists and grant certificates of
registration.
 Hold examinations for the purpose of registration.
 Lay down the standard of teaching to be maintained
by the institutions

48. Short notes on DA, DGDA

49. DA (Drug Administration)
 Founded: 1976
 Founder: MD. Mustafizur Rahman
 Headquarters: Motijheel Commercial Area, Dhaka,
Bangladesh.
 number of employee: 700
 website: www.dgda.gov. bd

51. DGDA (Directorate General of
Drug Administration)
 Founded: 1976
 Founder: MD. Mustafizur Rahman
 Headquarters: Mohakhali, Dhaka-1212, Bangladesh
 Tel : 8802 9880803,
 Fax : 8802 988054,
 Email : dgda.gov@gmail.com
 website: www.dgda.gov.bd

52. Function of DGDA
 Evaluate the proposals of new projects of all systems of
medicines.
 Issue and renew the drug manufacturing licenses.
 Issue and renew the retail and whole sale drug
licenses.
 Register and renew of drug products.
 Inspect the pharmaceutical establishments.
 Fix the price and certify the price of drug products.
Major Function of DGDA

53. Continue…….
 Approve the indent for import of finished drugs.
 Prosecute the cases of the drug courts and other courts
 Issue the export licenses of FSC (Free Sales
Certificate), GMP (Good ManufacturingPractices)
Certificate & CPP ( Certificate for Pharmaceutical
Products.).
 Approve the block list for the import of raw- and
packaging materials.

54. Short notes on WHO,
USFDA, MHRA, TGA

55. WHO(World Health Organization)
 Founded: April 7, 1948
 Founders: France, Denmark,
Ecuador, Australia, Canada.
 Headquarters: Geneva, Switzerland
 Customer service: +1 202-974-3000
 Parent organization: United
Nations
 Awards: Lasker-Bloomberg Public
Service Award

56. USFDA (United States of Food and
Drug Administration)
 Founded: 1906
 Founder: U. S. federal government.
 Headquarters: White Oak Campus, 10903 New
Hampshire Silver Spring, Maryland 20993
 Employees :14,824
 Annual budget: $4.36 billion
 Website: www.usfda.gov

57. MHRA (Medicines and Healthcare
Products Regulatory Agency)
 Founded: 1 April 2003; 12 years ago
 Founder: Minister: George Freeman MP ,
 Headquarters: London, United Kingdom
 key people: Sir Michael Rawlins, Chairman
Dr Ian Hudson, Chief Executive
 Website: www.gov.uk/mhra

58. Student ID:
161211001

59. MHRA main activities are
 Assessing the safety, quality and efficacy of medicines.
 Overseeing the UK Notified Bodies that audit medical
device manufacturers.
 Operating post-marketing surveillance, reporting,
investigating and monitoring adverse reactions of
medicines.
 Taking any necessary action to safe-guard public
health, restricting the availability of products or
improving designs.

60. Continue……………
 operating a proactive compliance programme for medical
devices.
 operating a quality surveillance system to sample and test
medicines and to address quality defects, monitoring the
 safety and quality of imported unlicensed medicines and
investigating Internet sales and potential counterfeiting of
medicines.
 regulating clinical trials of medicines and medical devices.
 promoting good practice in the safe use of medicines and
medical devices.

61. Continue………
 monitoring and ensuring compliance with statutory
obligations relating to medicines.
 managing the British Pharmacopoeia (BP), offering
scientific, technical and regulatory advice on
medicines and medical devices.
 providing the public and professions with
authoritative information.

62. TGA(Therapeutic Goods
Administration)
 founded: 1989
 founder: Joshua Jacobs
 headquarters: 136 Narrabundah Ln, Symonston ACT
2609, Australia
 website: www.tga.gov.au/
 Activities: medicines, medical devices, gene
technology, and blood products in Australia .

63. Current list of top 10 world wide
pharmaceuticals company
 Jhonson and Jhonson
 Novartis
 Roche
 Pfizer
 Sanofi
 Merck
 Glaxosmith kine
 Astra Zeneca
 Bayer
 Gilead Sciences

64. 2015 ranking of the global top 10 biotech and
pharmaceutical companies based on revenue (in billion
U.S. dollars)
Johnson &
Johnson, 74.3
Novartis,
49.6
Roche, 49.6
Pfizer, 47.7
Sanofi,
42.2
Merck, 41.2
gsk, 35.8
Astra
Zeneca,
24.7
Bayer, 20.1
Sales

65. 2015 ranking of the global top 10 biotech
and pharmaceutical companies based on
revenue (in billion U.S. dollars)
Johnson &
Johnson, 74.3
Novartis, 49.6Roche, 49.6Pfizer, 47.7
Sanofi, 42.2
Merck, 41.2
gsk, 35.8
Astra Zeneca,
24.7Bayer, 20.1
0
10
20
30
40
50
60
70
80
Sales

66. World wide top 5 pharmaceutical
company's details:

67.  headquarters: Johnson & Johnson Plaza in New
Brunswick, New Jersey
 Founded: New Brunswick, New Jersey, United States
(1886; 130 years ago)
 Founders: Robert Wood Johnson I James Wood
Johnson Edward Mead Johnson
 Area served : Worldwide
 Key people :Alex Gorsky (Chairman and CEO )

68. Continue…………
 Revenue: $ 74.331 billion
 Operating income: $ 20.563 billion
 Net income: $ 16.323 billion
 Total assets: $ 131.119 billion
 Total equity: $ 69.752 billion
 Number of employees: 126,500

69.  headquarters: Basel
 Founded: 1996 (from merger)
 Headquarters: Basel , Switzerland
 Key people: Joerg Reinhardt (Chairman), Joseph
Jimenez (CEO)
 Products : Pharmaceuticals, generic drugs , over- the-
counter drugs , vaccines , diagnostics , contact lenses ,
animal health.

70. Continue…………
 Revenue: US$ 50.359 billion
 Operating income: US$8.845 billion
 Net income: US$17.783 billion
 Total assets: US$131.55 billion
 Total equity: US$77.046 billion
 Number of employees: 118,700

71.  Industry: Pharmaceuticals
 Founded: 1896
 Founder: Fritz Hoffmann-La Roche
 Headquarters: Basel , Switzerland
 Key people: Christoph Franz (Chairman of the board),
Severin Schwan (CEO ), Daniel O'Day ( COO,
Pharmaceuticals), Roland Diggelmann
(COO,Diagnostics)

72. Continue……..
 Products: Pharmaceuticals and diagnostics
 Revenue :47.462 billion Swiss francs (CHF)
 Operating income: CHF 14.090 billion
 Profit CHF :9.535 billion
 Total assets :CHF 47.272 billion
 Total equity: CHF 21.558 billion
 Number of employees :88,509

73.  Founded 1849; 167 years ago
 Founder: Charles Pfizer, Charles F. Erhart
 Headquarters: New York City , United States
 Area served: Worldwide
 Key people: Ian Read (Chairman & CEO)
 Products: Atorvastatin, Prevnar, Norvasc, Norvasc,
Zithromax etc..

74. Continue……..
 Revenue: US$ 48.85 billion
 Operating income: US$11.05 billion
 Net income: US$7.74 billion
 Total assets: US$169.3 billion
 Total equity: US$71.30 billion
 Number of employees: 78,300

75.  Founder: Jean-François Dehecq (Original Founder)
 Headquarters: 82, Avenue Raspail, Gentilly , France
 Key people: Olivier Brandicourt (CEO, Chairman),
Jean-François Dehecq (Original Founder)
 Products: Prescription and over-the-counter drugs for
thrombosis , cardiovascular disease, diabetes , central
nervous system disorders, oncology and internal
medicine , vaccines.

76. Continue………..
 Operating income: €6.14 billion
 Profit: €4.39 billion
 Total assets: €96.07 billion
 Total equity: €56.89 billion
 Number of employees: 112,128

79. Top 20 Pharmaceutical Company
in Bangladesh
 Square
 Beximco
 INCEPTA PHARMA
 OPSONIN PHARMA
 RENATA
 ESKAYEF
 ACME
 ACI
 ARISTOPHARMA
 SANOFI AVENTIS
 DRUG INTERNATIONAL
 HEALTHCARE PHARMA
 IBN SINA
 NOVO NORDISK
 ORION PHARMA LTD
 GLAXOSMITHKLINE
 SANDOZ
 GENERAL
 NOVARTIS
 POPULAR PHARMA

80. Brief on top 5 Pharmaceutical
companies of Bangladesh

81.  Founded: 1958
 Founder: Samson H. Chowdhury
 Headquarters: Dhaka, set beside the Buriganga River.
 Key people :Tapan Chowdhury, Samson H.
Chowdhury, Anjan Chowdhury
 Products:Sedno,Square Zinc,Uriten
 Website: http://www.squarepharma.com.bd/

83.  Founded: 1972
 Founder: Sohail Rahman is the Chairman and
founder of Beximco.
 Headquarters: Dhaka , Bangladesh.
 Key people: ASF Rahman (Chairman), Salman F
Rahman (Vice Chairman)
 Products:Napa,Flubex,Neoceptin-R,Nitrosol,Tycil
 Revenue: $2 billion (estimated)
 Number of employees: 48,000
 Website: website: www.beximcopharma .com/

84.  Founded: 1999
 Founder: Abdul Muktadir
 Headquarters: Shahid Tajuddin Ahmed Sarani, Tejgaon
I/A, Dhaka , Bangladesh
 Key people :
 Managing Director and Chairman: Abdul Muktadir
 Strategy: S. Rahman
 Products :Aritone-Z,Carvista,Magfin,Reset
 Revenue: 1.6 billion
 Number of employees: Anonymous
 Website; http://www.inceptapharma.com/index.php.

85.  Founded: 1956
 Founder: Late Abdul Khaleque Khan
 Headquarters: 30 New Eskaton, Dhaka, Bangladesh
 Key people: Moudood Choudhury Deputy Manager.
 Products:Hypen SR,Tadol,Bislol,Diclofen,Urinom
 Revenue: Above US$100 Million
 Number of employees: 5001-10,000
 Website http://www.opsonin-pharma.com

86.  Founded: 1993
 Founder: Syed S Kaiser Kabir - CEO
 Headquarters: Mirpur , Dhaka , Bangladesh
 Key people: Syed S Kaiser Kabir – CEO
 Products:Anorexon,Calcin,Cardipin,V-cap
 Revenue: taka 36 billion
 Number of employees: 4,334
 Website: www.renata-ltd.com

87. Local Market Share In Medicine
Marketing:
Source:The Bangladesh Pharmacutical Index
18.70
9.80
8.60
5.30
5.00
52.60
Sales
Square
Beximco
Incepta
Opsonin
Renata
Others

88. GMP(Good Manufacturing
Practices)
Defination
 A GMP is a system for ensuring that products are
consistently produced and controlled according to
quality standards.
 designed to minimize the risks involved in any
pharmaceutical production.

90. Importance
GMP is a critical concept in pharmaceutical industry.
Many countries have legislated GMP procedures for the
manufacturing units, with an aim to ensure the quality
of medicines and thereby safeguard the health of
patients. If the manufacturers fail to comply with the
standards, their license may be cancelled or their
product may be banned, and they may be charged for
negligence/ non-compliance.
 Good Manufacturing Practices (GMPs) are systems
created and mandated by the government to regulate
production, verification and validation of drugs, food
and/or medical devices, ensuring that finished
products are effective and safe for market distribution.

91. Importance
It’s important to have GMPs because they are guidelines
which are enacted to ensure food, drugs, cosmetics,
medical devices and related products have no harmful
substances. These regulations, enforced by the FDA,
help reduce the instances of product recalls, harmful
effects and eventual lawsuits that may arise from
defective products.

92. Requirement
Manufacturing facilities must maintain a clean and hygienic
manufacturing area.
Controlled environmental conditions in order to prevent cross
contamination of food or drug product from adulterants that may
render the product unsafe for human consumption.
Manufacturing processes are clearly defined and controlled. All
critical processes are validated to ensure consistency and
compliance with specifications.
Manufacturing processes are controlled, and any changes to the
process are evaluated. Changes that have an impact on the quality
of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous
language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Cross contamination with unlabelled major allergens is prevented.

93.  Records are made, manually or by instruments, during
manufacture that demonstrate that all the steps required by the
defined procedures and instructions were in fact taken and that
the quantity and quality of the food or drug was as expected.
Deviations are investigated and documented.
 Records of manufacture (including distribution) that enable the
complete history of a batch to be traced are retained in a
comprehensible and accessible form.
 The distribution of the food or drugs minimizes any risk to their
quality.
 A system is available for recalling any batch from sale or supply.
 Complaints about marketed products are examined, the causes
of quality defects are investigated, and appropriate measures are
taken with respect to the defective products and to prevent
recurrence.

94. Practices are recommended with the goal of
safeguarding the health of consumers and patients as
well as producing good quality food, medicine, medical
devices, or active pharmaceutical products. In the
United States, a food or drug may be deemed
"adulterated" if it has passed all of the specifications
tests, but is found to be manufactured in a facility or
condition which violates or does not comply with
current good manufacturing guideline. Therefore,
complying with GMP is mandatory in all pharmaceutical
manufacturing, and most food processing.