Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
Schedule M for Pharmacy Students, Here from Pharmaceutical Jurisprudence 5th Sem.
Make easy in Student language.
Both Pharmacy Students (B Pharm & D Pharmacy
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
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Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
2. DEFINITION :
2
Line clearance is a structured procedure for ensuring that the equipment
and work area are free of products, documents and materials from the
previous process that are not required for the next scheduled process, and
that the equipment is clean and ready for the next scheduled process.
Type A:
Applicable for Product to Product change over.
Type B:
Applicable for Batch to Batch change over of
the same product/if no activity is present..
Type C:
Shift end cleaning./
Applicable for the processing rooms which are
not used during the day otherwise the same
batch is going on for the next day.
3. 3
To avoid mix up & Cross contamination from one
product to other or from one batch to other batch.
Purpose :
7. MIX-UP
7
A Mix–Up may be defined as:
-An unplanned combination of various compounds.
-A mistake brought about wrongly identifying one
material for another.
A mix-up can be caused by bad judgment or lack
of attention to detail, i.e., human error.
It can also occur through poor communication
between personnel.
8. CAUSES OF MIX-UP :
8
-The close proximity or location of similar items
( e.g. Atasin 40 Tablet & Atasin 80 Tablet Foil,S-1 )
- Items having the same colour or combination of
colours ( e.g. White & Off-White )
- Multiple products handled at the same
time/packaging
- Use of the same apparatus or equipment for
multiple products
- Improper storage of sterile and non-sterile
products
- Care not being taken during packaging and/or
repackaging of products
- Mistakes made when dispensing
- No proper line clearance procedure
- Unused labels or earlier production left in the
production area
- Improper documentation and labeling
9. 9
- No ID code on materials or
products
- Inadequate training of personnel
- Failure of the processing equipment
- Manual packaging and repacking
- Inadequate control or procedures
- Rejection of handling
- Improper affixing of labels
- Reprocessing
CAUSES OF MIX-UP : -Vendor’s Location, for example the
printer may be located some distance
from the PC or device that sends the
output to the printer. The wrong
person may mistakenly use the wrong
printout e.g., for labels.
- Improper or lack of proper
communication
- Same personnel handling two
machines or equipment at the same
time
- Lack of proper validation
10. 10
Learning Points:
Importance of Line
clearance
Separation of different line
Before Manufacturing
Preparation of
Manufacturing
Before Packaging
Preparation of Packaging
11. 11
Importance of Line Clearance
All manufacturing machines, containers and areas should be properly
cleaned and checked to prevent cross contamination or particulate
contamination of products.
All packaging and labeling components must be removed from
machines as soon as a run has been completed to prevent components
just used from mixing in with the components for the next run.
12. LINE CLEARANCE
12
Line clearance is the permission taken from the authorized QA person before starting
actual production (Manufacturing, Filling and Packaging).
The term line clearance is used for the documented act of conducting any
necessary removal of products and materials from a manufacturing line to prepare
the line for the next production(packaging).
A line clearance procedure is having three stages:
1.Clearing:-Remove the previous product related items from the area/line i.e. pre
printed ampoules , plugs , left over solution/material , product , labels , printed
cartons.
2.Cleaning:-Cleaning to be carried out only after clearing of previous products.
Clean the as per current SOP.
3.Checking:-Checking to be carried out only after clearing and cleaning of
previous products.
13. 13
Separation of different line
cGMP regulation requires that Packaging line and Manufacturing line
and each packaging line and each manufacturing line must be kept
separate from each other by appropriate space and partitions
Manufacturing
Lines
Packaging
Lines
Each Packaging
Lines
Each Packaging
Lines
14. 14
Before Starting Manufacturing
Prior to start the production operation, determine the
suitability of the gowning, environmental controls,
processing line, equipment, and materials.
Line clearance approval should be taken from both
Production & QA Department.
15. 15
Before Starting Manufacturing
Prepare the production area by completing the following tasks:
Clearing :
remove all documentation, materials, and equipment
from the previous production operation.
Cleaning :
clean the line and associated equipment according to
established procedures :
Checking :
Complete all appropriate entries into logs for equipment
maintenance and calibration
Place only documentation, materials, and equipment
designated for the scheduled production operation in the
area.
Verify environmental controls are operational and within
established limits
16. 16
Before Starting Manufacturing
Notify Quality Assurance and request a line clearance check
for the area.
Obtain a Line Clearance Checklist. and complete the top
section for operation name, date, part number, and lot
number.
At the completion of the inspection, sign and date the form.
Attach the form to the history record for the production lot.
17. 17
Preparation of equipment before any
manufacturing begins
All equipment and utensils must be properly maintained,
cleaned and record must be kept.
All major manufacturing equipment, storage containers
and processing lines must be marked with the product
name and lot number.
All major equipment must have their identification
number recorded in the Batch Production Record
18. 18
cGMP Regulation
The product must be manufactured as stated in the Batch
Production Record and according to SOP’s.
At the completion of each manufacturing step, the Batch
Production Record must be signed in the appropriate space by
the person performing the job immediately after it is done.
During manufacturing In-process testing is done by Production and
Quality Assurance.
At any point, adjustments to bring the batch up to specifications may be
made according to the SOP’s
Adjustment must be properly recorded in the batch production record.
19. 19
We comply with cGMP regulations by
Carefully following the SOP’s
Properly completing all production forms
Making proper entries in each equipment log
book
20. 20
Preparation of Packaging
STEP 1
• Packaging lines and machines must be cleaned
and inspected.
STEP 2
• Packaging lines must be identified with proper
identifying lot number.
STEP 3
• Quality Assurance and Packaging Departments
give approval
21. 21
Preparation of Packaging
The packaging department follows the packaging directions for each
individual lot.
This includes affixing the lot number and expiration date
All lebeling and packaging materials go to a receiving area for inspection,
sampling and testing or examination by Quality Control to ensure that they
meet company standards.
Labels are in different sizes depending on their
– packages
– dosage forms and
– Strengths
All the labels for one product must be stored together with each type and size
label in its own compartment.
All label must be stored under lock and key. (in a limited access area.)
The use of on-line label printing equipment must be carefully controlled.
22. 22
cGMP Regulation
Every label must be accounted for with entries made in the
appropriate records.
All packaging and labeling components must be removed from
machines as soon as a run has been completed to prevent
components just used from mixing in with the components for the
next run.
Labeled and Packaged product must be examined during the packaging
operations to make sure that containers and cartons in each lot are correctly
labeled and packaged.
Unused coded labels must be destroyed.
Destroyed labels must be accounted with sign & date.