This document provides an overview of quality control procedures and responsibilities in a pharmaceutical quality control laboratory. It discusses the roles of the laboratory director and technicians. It describes routine control instruments, reagent handling and labeling procedures, and various sampling plans including single, double, continuous, and sequential sampling. Standard test procedures and documentation requirements are also outlined. The document establishes best practices for ensuring accurate and reliable testing in the quality control laboratory.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
Introduction to Quality Control Test for Surgical Products
Surgical dressing, Classification of Surgical dressings, Rubber and Oil impregnated materials
Presented by
G. Sateesh Chandra
Department of Pharmaceutical Analysis
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
Introduction to Quality Control Test for Surgical Products
Surgical dressing, Classification of Surgical dressings, Rubber and Oil impregnated materials
Presented by
G. Sateesh Chandra
Department of Pharmaceutical Analysis
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
GLP is an FDA regulation.
It is defined in OECD principles as ―a quality system concerned with organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
GLP extends to include food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.
GLP is a formal regulation that was created by the USFDA in 1978 having worldwide impact.
Non-US companies that wanted to do business with the United states or register their pharmacies in the United States had to comply with the United States GLP regulations.
In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard.
Quality and Integrity of the Safety Data
In the early 70’s FDA became aware of cases of ( PLP ) poor laboratory practice all over the United States.
FDA decided to do an in-depth investigation in 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices.
Examples of some of these ( PLP )poor lab practices found were: Equipment not been calibrated to standard form , therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study.
Pharmaceutical Validation: Role in Phamaceutical Industrykaunainfathema1
This is a brief presentation on various concepts under Pharamaceutical Validation including its importance, scope, history, authorities, types of validation, VMP; along with the ICH and WHO Guidelines to be followed for Calibration of Equipments.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
1. PREPARED BY: HELI N KARNAVAT GUIDED BY:
M.PHARM SEM-1 Ms.KRUPA THULA
ROLL NO:3 Assistant Professor
PMRA M.Pharm
LJ INSTITUTE OF PHARMACY
AHMEDABAD
1
2. CONTENTS
INTRODUCTION
RESPONSIBILITIES OF PERSONNELS
ROUTINE CONTROL INSTRUMENTS
REAGENTS
SAMPLING PLANS
STANDARD TEST PROCEDURES
PROTOCOL
DATA GENERATION AND STORAGE
QUALITY CONTROL DOCUMENTS
RETENTION SAMPLE
RECORDS
AUDITS OF QUALITY CONTROL FACILITIES
2
3. HISTORY OF QC LAB:
GLP is a formal regulation that was created by the FDA (United
states food and drug administration) in 1978.
Although GLP originated in the United States , it had a world
wide impact.
Non-US companies that wanted to do business with the United
states or register their pharmacies in the United States had to
comply with the United States GLP regulations.
They eventually started making GLP regulations in their home
countries.
In 1981 an organization named OECD (organization for
economic co-operation and development ) produced GLP
principles that are international standard.
3
4. Quality Control Area.-(as per
schedule M)
Quality Control Laboratories shall be independent of the
production areas.
Separate areas shall be provided each for physico-chemical,
biological, microbiological or radio-isotope analysis.
Separate instrument room with adequate area shall be
provided for sensitive and sophisticated instruments
employed for analysis.
Quality Control Laboratories shall be designed
appropriately for the operations to be carried out in them.
Adequate space shall be provided to avoid mix-ups and
cross-contamination. Sufficient and suitable storage space
shall be provided for test samples, retained samples,
reference standards, reagents and records.
4
5. Continued…
The design of the laboratory shall take into account the
suitability of construction materials and ventilation.
Separate air handling units and other requirements shall be
provided for biological, microbiological and radioisotopes
testing areas. The laboratory shall be provided with regular
supply of water of appropriate quality for cleaning and
testing purpose.
Quality Control Laboratory shall be divided into separate
sections i.e. for chemical, microbiological and wherever
required, biological testing. These shall have adequate area
for basis installation and for ancillary purposes. The
microbiology section shall have arrangements such as
airlocks and laminar air flow work station, wherever
considered necessary.
5
6. INTRODUCTION
QUALITY CONTROL:
Quality control deals with the system which accepts or rejects
any activities or
parameters which affects the quality of product and thus
prevent quality deficiency.
Q.C. is not confined to only laboratory operation but must be
involved in all decisions,
concerning with the quality of the product”
6
7. AS PER WHO
DEFINITION:
Q.C. is the part of GMP concerned with sampling,
specification, and testing and with the organization,
documentation and release procedure which ensure that the
necessary and relevant tests are actually carried out and those
materials are not released for use, nor product released for
sale or supply, until their quality has bee satisfactory.
7
8. WHO guidelines for Q.C laboratory:
Should be separated from production areas.
Areas where biological, microbiological or
radioisotope test methods are employed should be
separated from each other.
Control laboratory should be designed to suite the
operations to be carried out in them.
There should be adequate suitable storage space
for samples, reference standards and records.
8
9. QUALITY CONTROL
LABORATORY
ABOVE SHOWN IS THE
OVERVIEW OF A QUALITY
CONTROL LABORATORY OF A
REPUTED PHARMACEUTICAL
COMPANY.
9
Figure:1.1- Quality
Control Laboratory
11. LABORATORY DIRECTOR
Responsible for overall operation and administration of the
laboratory, including employment of competent qualified
personnels.
To ensure that laboratory develops and uses a quality
system approach to laboratory testing that provides
accurate and reliable patient test results.
Ongoing monitoring of each testing process used in
laboratory to identify potential problems that could result
in errors.
11
12. Continued…
Take corrective action.
Evaluate the corrective actions taken, to make sure that
they were effective and will not occur again.
To ensure that testing systems in laboratory provides
quality services in all aspects of test performance.
12
13. Lab technicians
To operate laboratory equipment and computers and
performs other assigned work, in accordance to
documented laboratory procedures.
To perform chemical analysis.
Responsible for operation of GC, Spectrophotometers,
balances, computers, etc. Responsible to be cross trained to
perform special laboratory functions.
Carry out sampling, testing, measuring, recording and
analysing .
provide all the required technical support to enable the
laboratory to function effectively whilst adhering to correct
procedures and health and safety guidelines.
13
14. Continued…
performing laboratory tests in order to produce
reliable and precise data to support scientific
investigations;
carrying out routine tasks accurately and following
strict methodologies to carry out analyses;
preparing specimens and samples;
constructing, maintaining and operating standard
laboratory equipment, for example centrifuges,
titrators, pipetting machines and pH meters;
14
15. Continued…
ensuring the laboratory is well-stocked and resourced;
recording and sometimes interpreting results to
present to senior colleagues
keeping up to date with technical developments,
especially those which can save time and improve
reliability.
following and ensuring strict safety procedures and
safety checks.
15
17. Normally practiced routine control includes:
The lab and instruments should be cleaned daily.
All the instruments should be validated and checked and the
results should be recorded.
The samples arrived in the lab should be noted in incoming
register.
Humidity and temperature of the lab should be recorded daily.
Log books should be filled correctly for every instrument used.
The results of the tests should be recorded appropriately.
Any fault in the instruments should be immediately reported to
the Q.C manager.
17
18. INSTRUMENT RELATED TERMS
o VERIFICATION: a quality control process used to
evaluate whether a product, service or system complies
with the regulations, specifications or conditions implied
by the standard.
o VALIDATION: is a quality assurance process of
establishing evidence that provides high degree of
assurance that the product meets its intended standards.
18
19. Continued…
o CALIBRATION: the set of operations that establishes the
relationship between values indicated by an instrument or
system and the corresponding known values of reference
standard.
o EQUIPMENT QUALIFICATION: the action of proving
that any equipment works properly and actually gives
accurate and reliable results.
19
20. Reagents
Reagent quality control records must be retained for 5
years.
Reagents shall be used and controlled according to
manufacturer’s recommendations.
All reagents and chemicals, including solvents and
materials used in tests and assays, should be of
appropriate quality.
Reagent should be purchased from reputable,
approved suppliers and should be accompanied by the
certificate of analysis, and the material safety data
sheet.
20
21. Preparation of reagents in
laboratory
responsibility for this task should be clearly specified
in the job description of the person assigned to carry it
out
prescribed procedures should be used which are in
accordance with published pharmacopoeial or other
standards where available. Records should be kept of
the preparation and standardization of volumetric
solutions.
21
22. The labels of all reagents should
clearly specify:
Name;
content;
manufacturer;
date received and date of opening of container;
concentration;
storage condition;
expiry date or retest date
22
24. The labels for volumetric solutions
prepared in the laboratory should
clearly specify:
Name;
Molarity(concentration);
Date of preparation and initials of technician/analyst;
Date of standardization and initials of
technician/analyst;
Standardization factor.
24
25. Transportation and subdivision of
reagents:
Whenever possible they should be transported in the
original containers;
When subdivision is necessary, clean containers
should be used and appropriately labelled.
All reagent containers should be visually inspected
to ensure that the seals are intact, both when they
are delivered to the store and when they are
distributed to the units.
25
26. Continued...
Reagents that appear to have been tampered with should
be rejected; however, this requirement may exceptionally
be waived if the identity and purity of the reagent
concerned can be confirmed by testing.
Water should be considered as a reagent. The appropriate
grade for a specific test should be used as described in the
pharmacopoeias or in an approved test when available.
Precautions should be taken to avoid contamination during
its supply, storage and distribution.
The quality of the water should be verified regularly to
ensure that the various grades of water meet the
appropriate specifications.
26
27. Continued…
Stocks of reagents should be maintained in a store under
the appropriate storage conditions (ambient temperature,
under refrigeration or frozen).
The store should contain a supply of clean bottles, vials,
spoons, funnels and labels, as required, for dispensing
reagents from larger to smaller containers.
Special equipment may be needed for the transfer of larger
volumes of corrosive liquids.
The person in charge of the store is responsible for looking
after the storage facilities and their inventory and for
noting the expiry date of chemicals and reagents.
Training may be needed in handling chemicals safely and
with the necessary care.
27
28. Sampling plan:
Sampling is an activity which is of crucial significance to the
quality control in Pharmaceutical and Healthcare industry
where necessary to take the samples.
Sampling at the end of a manufacturing process provides a
check on the adequacy of the quality control procedures of
the manufacturing department.
Sampling plan is detailed outline of which measurement
will be taken at what times,on which material,in what
manner,and by whom.
In quality control activity “sampling” is one of the major
activity
28
29. Continued…
In QC laboratory;
Procedure available for receiving, storage and handling of
samples for analysis.
Sample receiving procedure should be documented and keep
it.
Each sample having distinct identification number and
information for its storage with handling and labeling.
Storage condition facilities in laboratory like refrigerator and
absence of light.
Detailed description of sub sampling of samples for analysis.
Reserve samples should be retained for additional testing if
quantity is adequate.
29
30. Continued…
Sampling may be required for different purposes for example;
Acceptance of batches
Clearance of batches
In process controls
Stability studies
Complaints
The control that applied to the samples may be;
Checking the identity of materials
Performing complete Pharmacopoeia or testing
Performing the special test
30
31. Sampling kit
The QC person may require the tools and equipment for collecting the
samples (Sampling kit).
The tools are knives, pliers, saws, hammers, wrenches etc. to open
packages, barrels and containers.
Not used the complicated tools for sampling of samples.
Pipette with suction bulb use for liquid of low viscosity.
Glass rod can be used for highly viscous liquid
Spatulas and scoops used for granules.
When it is necessary to take sample of materials at three different
strata (Top, Middle, Bottom) sampling stick used.
31
32. Continued…
All tools and implements should be kept
scrupulously clean before use, washed it
thoroughly with water or suitable solvents and
then dried.
It will be better if more than one set of sampling
kits are available in clean and dry condition.
32
33. Types of sampling:
Single sampling.
Double sampling.
Continuous Sampling.
Sequential Sampling
33
34. Single sampling:
A single sampling plan is defined by sample size, n, and the
acceptance number c. Say there are N total items in a lot. Choose
n of the items at random. If at least c of the items are
unacceptable, reject the lot.
N=LOT NUMBER
For a single sampling plan, one sample of items is selected at
random from a lot and the disposition of the lot is determined
from the resulting information. These plans are also denoted as
(n,c) plans since there are n observations and the lot is rejected if
there are more than c defectives.
Single sample plans are the most common and easiest plans to
use. However, they are not the most efficient in terms of the
average number of samples needed.
34
35. 35
Inspect n
pieces in a
sample
If the number defective found in sample
Accept the
lot
Equals or
exceeds r
Does not
exceed c
Do not
accept lot
n= sample size,
c= allowable no. of defect in the sample,
r= rejection no.
Fig:1.3 SINGLE SAMPLING CHART.
36. DOULE SAMPLING
Double and multiple sampling plans were invented to give a
questionable lot another chance. For example, if in double sampling
the results of the first sample are not conclusive with regard to
accepting or rejecting, a second sample is taken. Application of double
sampling requires that a first sample of size n1 is taken at random from
the (large) lot. The number of defectives is then counted and compared
to the first sample's acceptance number a1 and rejection number r1.
Denote the number of defectives in sample 1 by d1 and in sample 2 by
d2, then:
If d1≤a1, the lot is accepted.
If d1≥r1, the lot is rejected.
If a1<d1<r1, a second sample is taken.
36
37. Continued…
If a second sample of size n2 is taken, the number of
defectives, d2, is counted. The total number of
defectives is D2=d1+d2. Now this is compared to the
acceptance number a2 and the rejection number r2 of
sample 2. In double sampling, r2=a2+1 to ensure a
decision on the sample.
If D2≤a2, the lot is accepted.
If D2≥r2, the lot is rejected.
37
38. 38
Inspect first sample,n1 pieces
Does not exceed , c1
Do not accept lot
Equals or
exceed r2
Does not
exceed c2Accept lot
Inspect asecond sample ,
n2 pieces
Equals or exceeds , r1
If the no. of defectives in the first sample
Exceeds c1 but does not exceed r1
If the no. of defectives in combined sample
Fig:1.4 DOUBLE SMAPLIN CHART
39. CONTINUOUS SAMPLING
Continuous sampling is used where product flow is
continuous and not easily grouped in lots. Two
parameters exist for continuous sampling. One is the
frequency (f) and the second is the clearing number
(i).
39
40. Continued…
Carrying out a continuous sampling plan is simple and
can be carried out in 3 steps.
1. Inspect all i data.
2. If no defects are found, randomly sample fraction f
of data and check again for defects.
3. Whenever a defect is found, correct the flaw and
repeat step 1.
40
41. SEQUENTIAL SAMPLING
Sequential sampling is different from single, double or
multiple sampling. Here one takes a sequence of
samples from a lot. How many total samples looked at
is a function of the results of the sampling process.
The sequence can be one sample at a time, and then
the sampling process is usually called item-by-item
sequential sampling. One can also select sample sizes
greater than one, in which case the process is referred
to as group sequential sampling.
41
42. STANDARD TEST PROCEDURE
An authorized written procedure giving instructions
for performing operations not necessarily specific to
a given product or material but of a more general
nature (e.g. equipment operation, maintenance and
cleaning; validation; cleaning of premises and
environmental control; sampling and inspection).
Certain SOPs may be used to supplement product-
specific master batch production documentation.
Sampling: -
There shall be written Standard Operating
Procedures for sampling which include the
person(s) authorized to take the samples.
42
43. Continued…
The sampling instruction shall include:
(a) The method of sampling and the sampling plan,
(b) The equipment to be used,
(c) any precautions to be observed to avoid contamination
of the material or any deterioration in its quality,
(d) The quantity of samples to be taken,
(e) instructions for any required sub-division or poling of
the samples,
(f) The types of sample containers to be used,
(g) any specific precautions to be observed, especially in
regard to sampling of sterile and hazardous materials.
Testing:
There shall be written procedures for testing materials
and products at different stages of manufacture,
describing the methods and equipment to be used. The
tests performed shall be recorded.
43
44. 44
Physical
Analysis
:
Description :
Diameter :Measure the diameter of approximately 6 tablet using Vernier
calipers.
Thickness : Measure the diameter of approximately 6 tablet using Vernier
calipers.
Hardness :Check the hardness of approximately 6 tablet using hardness
tester .
Friability :Note the accurate weight of 20 tablet. Keep it into drum of
friability apparatus and allow to rotate for 100 revolution at 25
RPM.
Disintegration :Place one tablet in each tube of basket rack assembly of
disintegration apparatus and observe the time period for
complete disintegration.
45. Identification
: Identification Test by HPLC.
The retention time of the major peak in the chromatogram
of sample preparation should correspond to that of in the
chromatogram of working std preparation in the assay.
Assay:
Mobile Phase: Take 45volume of water in 55 volume of
Acetonitrile and add 0.1 volume of triethylamine. Adjust
pH 3.5 using phosphoric acid and filter it.
Standard Preparation :
Dilute 69.3mg amlodipine besilate (50mg amlodipine)+
54.39 mg Lisinopril
(equal to Lisinopril Anhydrous ) working standard in
mobile phase to obtain 50ml Further dilute 5 ml in 25 ml in
mobile phase to get final concentration amlodipine 200
ppm / ml and Lisinopril Anhydrous 200 ppm/ml
45
46. Test Preparation :
Accurately weight of fine tablet powder equvalent to 10 mg Amlodipine
+10 mg Lisinopril Anhydrous and dissolve in 50 ml to mobile phase to
get final concentration amlodipine 200 ppm / ml and Lisinopril
Anhydrous 200 ppm/ml.
Column: C18
Flow rate: 1.0 ml / min.
Wavelength : 215 nm
Run Time : 15 min.
Procedure:
Inject 20 l of standard preparation and test preparation separately.
And calculate the %assay for each tablet individually.
Calculation:
% Assay = Area of Sample X Std. Dilution X Potency
Area of Std Sample Dilution 100
Limit : 90 % to 110 %
46
48. DEFINITION
Protocol is a system of rule about the correct way to act
in formal situation .
Each study shall have an approved written protocol
that clearly indicates the objective and all methods for
the conduct of study.
48
49. WHAT SHOULD A PROTOCOL
CONTAIN???
Every protocol needs to focus specifically on one type of
experiment to be performed.
Title and statement of the purpose of the study
Identification of the test and control articles by names,
chemical number or code number.
The name of the sponsor and the name and address of the
testing facility at which the study is being conducted.
The procedure for identification of the system
49
50. Continued…
Type and frequency of test, analysis and
measurements to be made.
Records to be maintained.
The date of approval of the protocol by the sponsor
and the dated signature of the study director.
50
51. Continued…
Each study shall have an approved written
protocol that clearly indicates the objectives and all
methods for the conduct of the study. The protocol
shall contain, as applicable, the following
information:
The requirement to indicate “all methods for the
conduct of the study” does not mean that all
laboratory SOPs must be reiterated in the protocol;
it is sufficient if the protocol indicates “what” will be
done and “when” it will be done. Laboratory SOPs
describe “how” each study activity is to be
performed.
51
52. Continued…
The description shall include specifications for
acceptable levels of contaminants that are reasonably
expected to be present in the materials and are known
to be capable of interfering with the purpose or
conduct of the study if present at levels greater than
established by the specifications.
Each dosage level, expressed in milligram per
kilogram of body weight or other appropriate units, of
the test or control article to be administered and the
method and frequency of administration.
The type and frequency of tests, analyses, and
measurements to be made.
52
54. Continued…
Storage facility for records should reflect the need to
preserve confidentially, integrity and logical retrieval.
Thought should be given to the susceptibility of the
records to damage from fire (heat), flood (humidity),
electric or magnetic fields, dust, solvents etc.
It is the responsibility of laboratory staff to ensure all
relevant documentation is kept for the specified
timeframes and to archive large quantities of
documentation that is to be kept long term but not
necessarily looked at on a regular basis.
54
55. PURPOSE
The purpose of this procedure is to describe the
requirements for the retention of laboratory
documentation under GMP and the disposal of such
documentation.
55
57. DEFINITION
A sample from every batch of product made and the
chemicals and components that make up a finished
good are kept for a set period of time for use as
reference material should be a problem with a specific
product or batch.
57
58. CONDITIONS TO BE MET
The sample shall consist of at least twice the quantity
necessary for all tests required to determine its compliance
with specification.
The sample shall be stored in controlled room temperature
expect where the product labeling or specification states
otherwise.
The sample shall be stored in the same primary container
enclosure system in which the product is marked or shipped,
or in one that has essentially the same characteristic.
The sample shall be securely stored in accordance with their
labels requirements and segregated from other material.
The conditions in the store area must be supervised and
recorded.
58
60. Continued…
Documentation is an essential part of the quality
management System.
The laboratory should establish and maintain
procedures to control and review all documents (both
internally generated and from external sources) that
form part of the quality documentation.
60
61. THE PROCEDURES SHOULD ENSURE
Each document, whether a technical or a quality
document, has a unique identifier, version number
and date of implementation;
Appropriate, authorized SOPs are available at the
relevant locations, e.g. near instruments;
Documents are kept up to date and reviewed as
required;
Any invalid document is removed and replaced with
the authorized, revised document with immediate
effect.
61
62. Continued…
A revised document includes references to the
previous documents.
Old, invalid documents are retained in the archives to
ensure traceability of the evolution of the procedures;
any copies are destroyed.
All relevant staff are trained for the new and revised
SOPs
Quality documentation, including records, is retained
for a minimum of five years.
62
64. DEFINITION
Any production, control, or distribution record that is
required to be maintained in compliance with this part
and is specifically associated with a batch of a drug
product shall be retained for at least 1 year after the
expiration date of the batch.
Quality management records should include reports
from internal (and external if performed) audits and
management reviews, as well as records of all
complaints and their investigations, including records
of possible corrective and preventive actions
64
65. CLOSURE AND LABELLING RECORDS
The identity and quantity of each shipment of each lot
of components,
Drug product containers, closures, and labeling;
The name of the supplier;
The supplier’s lot number(s) if known;
The receiving code and the date of receipt.
The name and location of the prime manufacturer, if
different from the supplier, shall be listed if known.
65
66. MASTER PRODUCTION AND CONTROL
RECORDS
The master manufacturing records should clearly
identify:
Name of product,
Product type,
Strength Ingredients to be added,
Name, alphanumeric code,
Amounts or dosage unit or percentage Amount of
each ingredient for a batch
Sequence of adding ingredients
66
67. Continued…
Equipment to be utilized designated by name and,
where appropriate, by number processing steps with
details of conditions such as time, temperature, speed
Special precautions and hazardous conditions which
exist and the necessary safety equipment to be used
Theoretical yields and actual yields (action levels)
Space for signature and date of operator/supervisor
performing or checking each significant step.
67