Report

MEETING MINUTES AND SUMMARY- DAY 1
Name of Organization: STRIDES ARCOLABS LIMITED
Purpose of Meeting: Introduction/Briefing
Date/ Time: 2nd June 2015/10:00am
Members Present: Shailesh Gaurav, Ryan Pinto, Kavita Tirumale, Puneet Chadha
1.Agenda/Topic –
* Introduction of interns to Strides
2. Discussion -
*About Strides and its history
*Various verticals in Strides and their roles
*Agenda for the training process
3. Action -
*Insight into the company's working and the various HR related functions.
*Differentiation of roles at each vertical and responsibilities played by each vertical towards
contribution in the net value of the company.
*Assignment of a project guide/leader (Mr.Ramaraju), who will be looking over the activites that will be
performed day to day.
4. Person Responsible -
Kavita Tirumale
Puneet Chadha

______________________________________________________________________________
MEETING MINUTES & SUMMARY- DAY 2
Purpose of Meeting: Plant tour
Date/ Time: 3rd June 2015/9:30am
Members Present: Mr. Vimal, Mr. Ramaraju, Mr. Jayaram, Kavita Tirumale, Puneet Chadha
1.Agenda/Topic –
* Plant tour at Suragajakanahalli and introduction of interns to project guide/leader.
2. Discussion -
*Various buildings present in plant and their functions/ roles in the production process.
*Importance of the different manufacturing buildings.
*Insight on the QA and QC labs (audit going on hence no access to labs as such)
*The various roles of Strides as a company and the benefits provided to employees/various programmes
offerred by the company. (Done by Mr. Jayaram)
3. Action
*The integration of the various verticals as a single entity, ie. the plant in itself and the
differentiation of roles admist the veriticals.
*Role of each manufacturing/administrative building and the hierarchy of people in these buildings.
*Insight into the various ideals and rules followed at Strides and the employee benefits and regulations
put forth by the company.
4. Person Responsible

Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
MEETING MINUTES & SUMMARY-DAY 3
Purpose of Meeting: Functioning of Planning and Stores
Date/ Time: 4th June 2015/9:00am
Members Present: Dhanasekhar K, Sathyanarayan Raju, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic -
(a) Functioning of the Planning and role of the Deputy Manager in planning
(b) Functioning of the Stores and role of the Head of stores
2. Discussion -
*Importance of Planning team in the overall functioning of the plant and the the relation of the planning
to each and every step in the production process - from the beginning to the end.
*Importance of the Stores and storage and the functioning of the warehouse in the storage of materials
- right from the raw materials to the finished goods.
3. Action
*The planning team adheres to the functions of all the departments starting from the Business
development team to the Dispatchment of the goods (FGTN-Finished Goods Transport Number). All
activities related to the production process are first approved by the planning department.
*The warehouses are an extremely important step in the production process as the procurement of raw
materials as well as final dispachment of finished goods is done by the Stores head. The quality and the

quantity of the product are both controlled by the Stores department and is quintessential in the
production line.
4. Person responsible
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Stores and Packaging unit - tour of the units
Date/ Time: 5nd June 2015/10:00am
Members Present: Mr. Subramanya K, Mr. Ishwar Bhatt, Kavita Tirumale, Puneet Chadha
1.Agenda/Topic –
* To get an overview of the Stores and Packing units and get an idea of the
processes involved in the same.
2.Discussion -
*Raw Materials(RM) department and the different processes under it.
*Packing Materials(PM) department and the different processes under it.
*Understanding the various production lines(17 different) and their role in the product manufacturing.
3.Action
RAW MATERIALS

*Visited the 4 different storage areas and their classification based on temp and Relative Humidity (R.H)
(R.H) in the RM department
a) Cold (2-8)
b) Cool (15-25)
c) Ambient (32-35)
d) R.H
(all temp. in degree celcius)
* Visited areas for storage/loading and unloading of exipients and API(Active Pharma. Ingredients)
* Entry and Exit procedure for Raw Materials stores.
* Method of recording data and documentation.
PACKING MATERIALS
*Visited the 4 different storage areas and their classification based on temp and Relative Humidity (R.H)
(R.H) in the PM department
a) Cold (2-8) - observation of actual cold storage
b) Cool (15-25)
c) Ambient (32-35)
d) R.H (hard capsules require this)
(all temp. in degree celcius)
* Visited areas for storage and dispatching - boxing, paletting, cellophine wrapping, final dispatching.
* Rules and regulations involved while entering restricted areas.
* Method of recording data and documentation of the same.

The various production lines were visited and their role in pacakging and storage was explained
* 17 lines in total
* Division of labour admist lines to ease out work load
* Differentiation of work load within each production line to speed up work
4. PEOPLE RESPONSIBLE
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Details on Planning Unit
Date/ Time: 8th June 2015/11:15am
Members Present: Dhanasekhar K, Vimal Kumar SM, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Detailed Discussion on planning
2. Discussion -
a)FGTN (Finished Goods Transfer Note) - Sales Order (SO) list
b)QC release plan
c)Day wise plan
d)Shipment plan

3.Action -
*Process Flow for Planning
BUISNESS DEVELOPMENT
SUPPLY CHAIN MANAGEMENT
QC/QA
DISPATCH
PACKAGING
PRODUCTION
QC
a)Sales order from customers
b) Procedure
-Granulation of the exipients and API (Active Pharma Ingredients)
-Blending
-Compressing
-Coating
c) Dispatching
DIFOT - Delivery In Full & On Time
d) Various inputs and outputs for different processes
* Input for Manufaturing -> Raw Materials (RM) -> Output is Semi Finished Goods (SFG)
* Input for packaging -> Semi Finished Goods -> Output is Finished Goods (FG)
4. PEOPLE RESPONSIBLE
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________

Purpose of Meeting: Soft gel production
Date/ Time: 9th June, 2015/9:00am
Members Present: Rushyendra Babu, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic -
*Visiting of the Soft Gel Production line and explanation of the various processes involved
2. Discussion -
a)Raw materials involved in the production process - their procurement, storage and processing
b)Components that comprise the shell
c)Filling (4 lines)
d)Encapsulation (4 lines)
Rotary Die Process and its function in production
(i) Tumble Dryer
(ii)Tunnel Dryer
e)Sorting
f)Wiping
g)Inspection
h)Printing
3. Action
a) Raw materials used in the process are :-
*Glycerin
* Sorbitol
* Water

These materials are first procured based on the daily and weekly requirements and then are stored in
the raw materials storage area until they are put to use
b) Components that comprise the shell are :-
* Shell
* Filling material
c)Filling - Process of production of the homogeneous fill material that comprises the capsule
d) Encapsulation :-
Rotary Die Process is a process of encapsulation that brings the gelatin shell and the fill material
together to form the soft gel capsule. This happens in a closed and regulated environment called the
clean room - maintainance of temperature and R.H.(Relative Humidity)
(i) Tumble Dryer - Process of removal of moisture content to avoid of adhesion/sticking of tablets
Time period - 2-3 hours
Temperatre - Low
R.H - High
(ii) Tunnel Dryer - Natural manual drying process - multiple trays of capsules (alligned one on top
of the other)
Temperature - High
R.H - Low
e), f), g)
Sorting, Wiping and Inspection - Originally all processes done manually and separately
Now, useage of automated machine that incorporates all these processes into one machine (to avoid
human error)
h) Printing - Some capsules require the printing of text on on the capsule itself
Kavita Tirumale

Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Meeting and overview of R&D department
Members Present: Mr. Anil Kumar R , Vimal Kumar SM, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic -
Meeting with the head of R&D - Formulation and Development
2. Discussion -
a) Generic manufacturing done by STRIDES
b) Macro and Micro drug production
c) Filing
d) Patent challenging
e) Stability requirements
(i) Pilot Study
(ii) Bioequivalence Studies
f) Scaling up
3.Action -
a) Strides is invovled majorly in the generic production of medicines, ie. the production of a medicine

after aquiring patent rights from the innovator. The company does not lie much in the innovation of
novel products. Eg: Pfizer is an innovator company
b) The drugs can be broadly classified based on the type of molecule being produced:-
(i) Macromolecules - do not contribute to much of today's production globally
(ii) Micromolecules - 80% contribution in th eglobal market
- They include cancer drugs like Amphotericin
c) Filing - It is the process of defining of a strategy
d) Patent Challenging -
*Once a patent is filed by an innovator, the invention remains his/her copyright for a period of 18-20
years (pharmaceutical industry - oral molecule)
* Within this period, it is against the law for any other company to use the same process for production
of the same product
* If an individual/company wishes to do so, then they must invent a novel process for producing the
same
* Once the patent expires, the product can now be acquired by other companies for generic production
* STRIDES pertains to generic production of drugs
e) Stability Requirements comprise the following studies :-
(i) Pilot Study - It is a standard specific tool which allows scientists to conduct a preliminary analysis
before the commercialisation of the process
(ii) Bioequivalence Studies - In the pharmaceutical industry, it is the process of the comparison of
studies conducted on the blood levels of individuals to determine the quality of the drug and whether
or not it has the same effects as the original one.
f) Scaling up -
*It is the process of producing a large batch size after approval from the R&D department for
commercial use
* In the pharmaceutical industry the submission batch(Base Batch) is generally 120,000 tablets/capsules
in size whereas the commercial production is done in batches of 1.2 million in number
* Care must be taken while scaling up so as to maintain quality

4.Person Responsible -
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Detailed viewing of Soft Gel Production line
Members Present: Mr. Rushyendra Babu, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic
To understand the working of the Soft Gel Production line and to ask questions about the different
processes involved in the production
2. Discussion -
a) Advantages of Soft Gel Capsules over Hard Gel/Tablets.
b) Source of Gelatine used in making of the outer covering of the capsule.
c) Use of Sorbitol as a raw material in making the outer covering of the capsule.
d) Alternative method(s) for encapsulation(other than Rotary Die Method).
e) Time duration :-
(i) Tumble Drying
(ii) Tunnel Drying
f) Role of IPQA in the production process.

3. Action
a) Advantages are the stability and the ease of delivery. Furthermore, unlike the hard gel capsules or
tablets, there is no coating for time delay. Thus, site of action is generally in the stomach where the
capsule degrades and releases the API/Filling Material
b) The Gelatine can be obtained from two sources :-
(i) Animal Source -> Obtained from the bone/skin of the animal
-> Easily procurable Raw Material and hence commonly used in most pharmaceutical
industries
(ii) Plant Source -> Polymers of cellulose can be used
-> Difficult to obtain and to use, thus not a common practice
c) Sorbitol acts as a sweetener as well as a humectant (a substance that prevents loss of moisture
content)
d) Other than Rotary Die Method, the Paint Ball Method (a less commonly known one) is also used by
some companies. STRIDES adheres to using of the Rotary Die Method . The machine used is known as
'Automatic Paintball Encapsulation Machine and Parallel Gelatine Supply'
e) Time Taken:-
(i) Tumble Drying has no such specific time of running
Eg: For production of Omega H3 capsules, the time duration is 2-2.5 hours
(ii) Tunnel Drying no such specific time of running
Eg: For production of Omega H3 capsules, the time duration is 90-95 hours
f) IPQA - In Process Quality Assurance
* Evaluate Quality, Ensure Stability, Check Weight Control, and Solubility Check
* Stability and Friability checking is done by the use of 5-7 Newton (N) of Force in order to check

whether the tablet retains its shape and size
*Dissolution time and Disintegration time tests are also performed by IPQA department
4. Person responsible
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Discussion of SOP's, GMP, GDP and their importance
Date/ Time: 12th June 2015/ 10:00am
Members Present: Singree Gowda, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic -
Discussion of SOP's, GMP, GDP and their importance
2. Discussion -
(i) How to prepare a SOP consists of :-
a)Purpose
b)Scope
c)Abbreviations
d)Responsibility
e)Definition
f)Procedure

g)Reference
(ii) GMP
(iii) GDP
Functions of the above and their importance in the functioning of the company
3.Action -
(i) SOP stands for Standard Operating Procedure and is a set of guidelines used for the preparation of
official documents as well as the steps/procedures to be followed in a specific area of work
-> Mandatory review every 3 years
* Review should be conducted in an ordered manner with the authorisation and signatures of
concerned
officials
* Once a review has been done, the old review should be retrieved and destroyed
Eg: If R6 is being reviewed, then R5 should be retrieved and destroyed
-> Consisits of :-
a) Purpose - It's the agenda/topic on which the SOP is to be made and thus varies from SOP to SOP
b) Scope - It is the work instructions that are to be followed during the process specific to the SOP
c) Abbreviations - Consits of a list of the short forms and their expansions that are used in the SOP
Eg: HOD - Head Of Department
d) Responsibility - This consists of a list of the names of the following people:-
* Performer
* CFT(Cross Functional Team)
* Supervisor
* QA(Quality Assurance)
e) Definition - This is an explanation of the terms used in the SOP

f) Procedure - It is the main body of the SOP and comprises the flow of events to be followed in the
particular process
g) References - It is a list of documents that have been used as a template for the SOP
(ii) GMP - It stands for Good Manufacturing Practices and contains all the aspects of production -
starting materials and equipment
The current GMP's followed as per the USFDA guidelines are:-
* Title 21 CFR
-> CFR Part 210
-> CFR Part 211
-> CFR Part 600: Biologics
-> CFR Part 820: Medical Devices
The GMP followed by the company is referred to as CGMP(Current Good Manufacturing Practices) and is
the document specific to the company
In general, GXP is the term used for the abbreviation of the several Good Practices. These may include
• GMP (Good Manufacturing Practices)
• GPP(Good Packing Practices)
• GLP(Good Laboratory Practices)
•
The 21 CFR 210 includes:-
* Status of the regulations
* Applicability of the regulations

The 21 CFR 211 includes:-
* Subpart A: General Provisions
* Subpart B: Organization & Personell
* Subpart C: Buildings & Facilities
* Subpart D: Eqipments & Other related topics
* Subpart E: Control of Components
* Subpart F: Production & Process controls
* Subpart G: Packing & Labeling Control
* Subpart H: Holding & Distributions
* Subpart I: Laboratory controls
* Subpart J: Records & Reports
* Subpart K: Return & Salvage of Drug Products
(iii) GDP stands for Good Documentation Practices
->It's main objective is to understand the need for documentation, it's types and to learn the
characteristics of good documentation
-> The main purpose of documentation is to assure that the quality standards are met
-> Two important rules while practicing documentation:-
* It should be documented correctly
* It should be legible
-> Documents can be of 3 types:-
* Directive
Eg: SOP (Standard Operating Procedure)
* Data Collection
Eg: Equipment Logbook

* Commitment
Eg: Quality Manual
4.PEOPLE RESPONSIBLE:
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: R&D Unit visit
Date/ Time: 12th June, 2015/2:00pm
Members Present: A. Sheker Reddy, Nilesh Aher, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Visit of the R&D production unit
2. Discussion -
a) Overview of R&D department and its function prior to large scale production
b) Laboratory visit
(i) Analytical Services Department (ASD)
(ii) Formulation and Development Department (FDD)
3. Action

a) R&D department is the first stage prior to large scale/commercial production and is thus one of the
most important units in a pharmaceutical company. It is a small-scale version of production and testing
which is compulsary for assurance of Quality. If the R&D products pass the required tests, then the
product is further sent for a scale-up - after which it is used for large-scale manufacturing
Steps invloved:-
-> Obtaining of Raw Materials(RM) and validation of the RM prior to testing
-> Prior to formulation, it must be ensured that the patent copyright is not being infringed upon in any
matter. Eg: Process Flow, Composition, Methodology of innovators
Eg: An innovator can file a patent for a specific class of chemicals(Eg: PEG) and this implies
that the generic manufacturers cannot use PEG, irrespective of the chain length
-> Formulation of components
* Different combinations of materials done to mimic process flow of innovator in order to obtain a
finished product of Bioequivalence to the innovators product
-> IPQA(In Process Quality Assurance) testing
-> Pilot Testing and Submission Batch
-> Approval for large scale production
b) The lab consists of two main divisions:-
(i) Analytical Services Department (ASD)
-> It comprises of machines that do quality testing of the raw materials
(ii) Formulation and Developement Department (FDD)
-> This can be thought to be a small scale version of the large scale production line
-> It produces batches of 10-100kg's as opposed to those produced in numbers of 1000-10000
kgs(commercial)
-> It comprises of the following steps:-
* Granulation
* Compression

* Drying
* Coating
* IPQA
* Storage
Kavita Tirumale
Puneet Chadha
______________________________________________________________________________
Purpose of Meeting: Quality Assurance Overview
Date/ Time: 15th June, 2015/4:00pm
Members Present: Mr.Shankar Krishnan, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Overview of the Quality Assurance department and it's importance in the functioning
of a pharmaceutical company
2. Discussion -
a) Quality Assurance(QA) can be broadly subdivided as:-
(i) IPQA (In Process Quality Assurance)
(ii) QMS (Quality Management System)
b) Quality Assurance(QA) is in charge of:-
(i) CQA (Corporate QA)
(ii) TSGQA (Technical Services Group QA)

(iii) Contract Manufacturing Team
c) Internal and External Auditing
d) Technical Training
3.Action -
a) (i) IPQA -
*It comprises of a system of checks that are performed throughout the manufacturing process
*It controls the activities on the shop floor
*Sampling of the intermediate products also done by the IPQA
*Eg: In the production of hard gel capsules/tablets, IPQA is responsible for a variety of tests
like the Friability tests
(ii) QMS -
* It verifies the documents
* It is a third eye on the IPQA
* It is not involved in the process of Batch Release
* Independent processing unit
* Addressing of mistakes, if any during Batch Processing
Eg:
Deviation In Unit --> Impact Assessment --> Quality ---> Assess --> Impact --> Release
b)
(i) CQA
* Internal Auditing
* Harmonization across facilities

(ii) TSGQA
* Monitors FDD(Formulation Development Department) and ASD(Analytical Services Department)
* Approval of specifications
(iii) Contract Manufacturing Team
c) Internal, External, and Vendor Auditing
(i) Internal
* To see the compliance status of the facility
* It is done on a regular basis to ensure the quality of the product
Eg: At STRIDES, Internal Auditing takes place once in 6 months across all facilities and
surprise internal audits are done to keep a check on the quality
* Six systems involved:
-> 2-3 auditors
-> 3-4 days (depending on size of plant)
-> Lacunae/Improvement Areas
-> Classification of errors
-> Response + Corrections to bridge the gap
-> CAPA (Corrective And Preventive Action)
* The errors/observations can be of three types:
-> Critical - Direct impact on patient safety
Eg: Diabetes medicine if exchanged with a hypertensive medicine can cause renal failure
-> Major - Impact on the GMP(Good Manufacturing Practices) but not on patient safety
Eg: Wrong labelling of a container

-> Minor - No impact on patient health as well as can be corrected easily
Eg: Documentation errors
(ii) External
* Regulatory - Comprises the regulatory bodies across the globe; USFDA, MRHA
* Customer - Can be performed at any time with a 24 hour notice by the customers being
supplied to
(iii) Vendor
* Audits performed by the company on the vendors to assure the quality of the supply
materials:
-> Raw Materials (RM)
--> API (Active Pharma Ingredients)
--> Exipients
-> Packaging Materials
d) Technical Training -
Three elements:
* Core Training - Delivery of content
* Skill - Educational background
* Competency - Ability to deliver based on core training and skill
The first technical training requires the employees to be thorough with:
* GDP (Good Documentation Practices)
* GMP (Good Manufacturing Practices)
* Personal Hygiene
The employees are then segregated on the basis of the department

The Job Description, ie. the set of responsibilities on a day to day basis. The training matrix is then
referred to, in order to allot to the employees a specific training schedule
Eg: Learning Management System (LMS) is followed at STRIDES
* Assigns the assessment
* Online training
* 100% marks to pass
* Qualified
Puneet Chadha
Kavita Tirumale
______________________________________________________________________________
MEETING MINUTES & SUMMARY-DAY 11,12&13
Purpose of Meeting: Detailed overview of Quality Assurance(QA) Department
Date/ Time: 16th June, 2015/9:00am-1:00pm
Members Present: Mr.Jaikumar Nandkumar, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Detailed overview of the QA department and the reading of the ICH (International
Conference on Harmonisation) guidelines
2. Discussion -
(i)The ICH guidelines are as follows:-

a) Q1A - Q1F -> Stability
b) Q2 -> Analytical Validation
c) Q3A - Q3D ->Impurities
d) Q4A - Q4D -> Pharmacopeia and their harmonisation
e) Q5A - Q5E -> Quality of Biotechnological Products
f) Q6A - Q6B - > Specification
g) Q7 -> GMP
h) Q8 -> Pharmaceutical Development
i) Q9 -> Quality Risk Management
j) Q10 -> Pharmaceutical Quality Systems
k) Q11 -> Development and Manufacture of Drug Substances
l) Q12 -> Life Cycle Management
(ii) Regulatory Bodies
3.Action -
(i)
a) Speaks about the Stability Testing of New Drug Substances(only Active Pharma Ingredients) and
Products (Finished Goods)
b) Speaks about the validation of analytical procedures
c) Speaks about impurities in New Drug Substances as well as Products
d) Speaks about Pharmacopoeias
e) Speaks about Quality of Biotechnological Products
f) Speaks about Specifications for Test Procedures and acceptance of New Drug Substances and Products
g) Most important document and consists of the following:-

(i) Introduction
The aim of the GMP is to provide guidance regarding the good manufacturing practices for the
manufacture of medicinal products. There are many different types of manufacturing and in each of
them, the GMP is applicable from a certain step in the process
Eg: If Chemical Manufacturing is being done then GMP is applicable from the introduction of the
API starting material(ie. the basic components that comprise the API) into the process and not from the
production of the API starting material
(ii) Quality Management
* Quality depends on all the people taking part in the manufacturing process and they should
establish, document and implement an effective system to manage the quality
* There should be independent QA and QC units in the organisation
* Any deviations should be recorded
* Internal Audits are performed to identify the gaps in the organisation and to implement
suitable corrective actions
(iii) Personnel
* This talks about the personnel qualification, and the hygienic practices to be followed while
manufacturing
* Qualification - There should be an ample number of employees with the necessary education training
and skill required to perform the activities assigned to them
* Hygiene - Performing of good health habits as an individual such as washing hands and wearing of
appropriate and clean clothes
* Includes the preventive measures taken for Pest Control - prevention of infection
There are three general areas of Pest Control within a production floor(general):
-> Bait Station

-> Control Measures (Perimeter)
-> Rodent Trap (Sticky area as a last resort to avoid the entry of pests)
(iv) Buildings and Facilities
* Design and Facilities - Assigning of an appropriate location for the designing and construction
of the buildings to facilitate cleaning, maintenance and operations
as required for the stage of manufacture
* Utilities - They should be qualified and appropriately monitored
Eg: Adequate ventilation and exhaust systems should be provided
* Water - Water is a universal solvent and thus is very important in the manufacturing of
drugs. Water is generally classified as follows:
-> Source - This is where the water is obtained from for example, a River or a bore well
-> Potable - This water is available for drinking purposes in the facility
-> Purified –
*Purified water has a quality standard of 500 parts per billion(ppb)
*It is generally kept at ambient temperature conditions
*At STRIDES, the purified water is kept at 60 degrees Celsius for all usage as the manufacturing units
generally require water at this temperature
-> WFI (Water For Injection) - *This is the purest form of water in a pharmaceutical industry and is
required to have a quality standard of 100 ppb (upper limit)
*The WFI is generally maintained at a temperature Of 80 degrees Celsius to inhibit the growth of
microorganisms
* The quality grade of steel used for WFI is SS316L and is a grade of electro polished steel that prevents
stagnation and keeps a check on the Total Organic Carbon (TOC)
* Containment - Preventive and precautionary measures to avoid cross-contamination
* Lighting - Some materials are photosensitive and thus require appropriate lighting conditions
* Sewage and Refuse - The drain system as per required by pharmaceutical companies is generally

of a specified GMP standard known as the double cup system which holds a liquid in the primary cup
and thus does not allow back siphoning along with preventing the entry of insects, rodents or any pests
(v) Process and Equipment
* Equipment should be of appropriate design as per specifications(adequate size), suitably located
for its use.
* Can be used only in its specified range and not beyond this limit
* Cleaning - There has to be a well maintained documentation system as per GDP for the cleaning
of machinery/equipment.
Eg: Non-dedicated equipment must be given more importance to as it operates under
different conditions and for different materials
* Calibration - The equipment must be calibrated prior to usage and regular checks must be
performed to ensure the smooth running of the machines
(vi) Documentation and Records
* All official papers regarding the manufacturers must be appropriately documented and stored
for future use as well as in case of a recall or any situation where CAPA is required to be
done
* API records must be retained for 3 years post distribution
* Batch Production - Contains information of the entire production and control of the batch
(vii) Materials Management
* A written procedure must be available, describing the processes from the quarantine to the
dispatching of the material
* Sampling and Testing of Materials - All test should be performed on each batch to assure that the
quality standard is maintained throughout

* Storage - Should be stored under specified conditions to avoid any form of contamination
(viii) Production and In-Process Control
* Weighing and measuring of the Raw Materials(RM) must be done by qualified professionals and then
sent for further processing
* Blending - Blending implies that different batches of the same RM are being mixed to suit the
customer requirements
Eg: The customer may have a requirement of a 100kg batch but the plant may have a maximum of 25kg
batch reactors. In such a case, Batch Blending is done wherein, 4 batches of 25kgs are mixed. As mixing
is being done, testing of the mixed batch must be done in every step of the way to ensure uniformity
(ix) Packaging and Identification Labelling
* The written procedure describing the processes from the recieval to the testing of the packaging of the
materials
* Labelling can be done only by an authorised personnel
(x) Storage and Distribution
* There must be appropriate Storage and Distribution facilities for the RM, PM, SFG as well as FG
* The different conditions must be maintained as per the requirements of the materials
Eg: ->Some materials may be photosensitive and may require a certain light environment, like
monochromatic light exposure
->Some materials may require ambient temperature conditions while others may require sub-zero
conditions
(xi) Laboratory Controls
* It is a set of documented procedures describing the processes from the sampling to the testing of the
materials.
* Each batch must be tested to ensure that they meet the specification requirements

(xii) Validation
* Quality validation is one of the most important processes while manufacturing and should be
followed for any system,process,equipment,method or test
* There are 5 basic steps that should be systematically followed to ensure the validation of
a system,process,equipment,method or test:
-> Documentation of evidence (If it's not documented, it's not done)
-> Process/Equipment/System/Method/Test
-> Performed or Operated at the set conditions
-> Consistent & Reproducible Results
-> Meets the acceptance criteria
Eg: Validation of a QC process must contain the documented evidence of the process which
when performed at the set conditions should reproduce consistent and reproducible
results that meet the acceptance criteria
(xiii) Change Control
* Evaluation of any changes to be made to the process and implementation of the same in a systematic
and organised manner
(xiv) Rejection and Re-usable Materials
* If the RM fail to meet the required specifications then they are rejected
* This is an extensive process that requires the usage of GDP in order to have a system of proof for the
rejected materials

(xv) Complain and Recall
* There should be a record of all complaints and recalls. A customer could issue a recall if the
specification criteria are not met with
* In such a case, a document must be produced, with all the details of the complaints; from the time and
date to the name and weight of the recalled material
* The materials are not disposed of immediately but are kept for a maximum time period of 1 year in
order to have access to the samples if any further complaints are obtained
* The materials, once expired must be disposed of in an appropriate manner as per the FDA guidelines
and the date and time of disposal must be recorded
(xvi) Contract Manufacturers
* The GMP must be followed while establishing a contract with the concerned authority
(xvii) Agents and Brokers
(xix) Clinical Trials
(xx) Glossary
h) Q8 - Pharmaceutical Development
i) Q9 - Quality Risk Management deals with the risks associated with the usage of different machines or
equipment and the required corrective and preventive actions to be taken to avoid any future
deviations regarding the same
j) Q10 - Pharmaceutical Quality Systems
k) Q11 - Development and Manufacture of Drug Substances
l) Q12 - Life Cycle Management is the most recent addition to the GMP

(ii) Regulatory Bodies - These are the authorities that are responsible for the setting up of guidelines to
be followed by the pharmaceutical companies
Eg: * USFDA (USA)
-> 21 CFR (Code of Federal Regulation)
--> 210
--> 211
* EMEA (Europe)
* TGA (Australia)
* ANVISA (Brazil)
* MHRA (Audit for EMEA)
Puneet Chadha
Kavita Tirumale
______________________________________________________________________________
MEETING MINUTES & SUMMARY-DAY 14&15
Purpose of Meeting: Overview of QC(Quality Control) Department
Date/ Time: 17th June, 2015/ 10:00am
Members Present: Mr.Mahesh, Mr. Chadrappa, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Overview of the QC functions and a visit to the associated QC labs

2. Discussion
(a) Function of QC (general)
(b) Different lines:-
(i) Raw Materials (RM)
(ii) Pacakaging Materials (PM)
(iii) Semi-Finished Goods (SFG)
(iv) Finished Goods (FG)
(vv) Validation
(vi) Stability
(vii) Lab Support System
3. Action
(a) The QC adheres to the following functions and plays the following roles in the manufactring process:-
* Receiving of material
* Testing of material
* Release of material
* Rejection of material
->(Material may be RM, PM, SFG or FG)
* It performs the Standard Test Procedures
* Any deviations that are observed are then given for CAPA (Corrrective And Preventive Action)
(b) The 6 lines of QC all operate under a similar series of steps which differ only on the basis of

the specific function performed by each. The following is w.r.t RM:
* The Raw Materials are recieved in the warehouse
* A Goods Reciept Note(GRN) is generated for every batch and is submitted to QC for sampling
* Pooling procedure is done to check for uniformity amongst the containers, ie. if all the batches
are similar
Eg: If a container contains 50 batches, then 20 of them are obtained and then samples from these
20 are pooled in and tested for quality
* QC enters all the data into the LIMS (Laboratory Information Management System) which is a
software
used for recording of the data by QC
* There is a register for the checklist of materials
* The physical appearance too must be tested and any anomaly must be noted and kept aside
* The QC ensures useage of Personl Protective (PP) equipment
* As each of the tests performed by the QC are material specific, only trained professionals must
be allowed to do so
Eg: 30 days of training ---> Analyst Test Qualification(assign release materials and compare with
the pre-released reciepts) ---> Assigning of senior job trainer ---> Assigning of specific job
* The tested materials must show up as green when entered into the LIMS - this means that they have
met the requirements. Any deviations show up as red and can be classified on the basis of:
-> OOS (Out Of Specification)
Out Of Specification means that the result is not within the specified limits
Eg: Limits: 95-105
Result: 94/106 => Out Of Specification
If it is an OOS then the following steps must be followed as a part of CAPA:
(i) Inform Senior
(ii) Logged into LIMS as OOS

(iii) Investigation
(iv) OOS form created
(v) Investigation form and check-list
(vi) Write down all the observations and hand to the superior
(vii) 40-50 check points are done (from glassware to the chemicals used)
(ix) If,
-> No deviation, then the material is sent for checking again
-> Yes, a deviatio is observed then the material is also sent for Triplicate testing
--> If the material passes the Triplicate testing, then it is concluded that there is
some deviation in the initial testing
--> If the material fails the test then it is tested again and sent to the QA to
determine the root cause after which a decision of release or reject is taken
* If there is no OOS or OOT observed then a test is done to compare to the Working Standards as well
as the reference standards (both obtained from pharmacopoeias)
* Once all the tests have been completed, the following steps are followed according to GDP & GMP
-> Enter into LIMS
-> UV printout(if necessary)
-> Backup made with proff attached
-> LIMS
-> Chromoatographs attached
-> Sent to QA for review
* The labs in STRIDES comprise of the following machines/equipments in the QC labs:-
(1) Refractometer

(2) Polarimeter
(3) HPLC(High Performance Liquid Chromatography)
(4) UV Spectrophotometer
(5) AAS (Atomic Absorption Spectrometer)
(6) Chloride Analyzer
(7) Sieve shaker
(8) Friabiliator
(9) Texture Analyzer
(10) TOC(Total Organic Carbon) Analyzer
(11) Physical parameter tester
(12) Differential Scanning Colorimeter (DSC)
(13) Muffle Furnace
(14) Hot Air Oven
(15) Glove Box
(16) Mili-Elix water filter - purifying water purposes
Puneet Chadha
Kavita Tirumale
______________________________________________________________________________
Purpose of Meeting: Overview of Packaging Department

Members Present: Mr. Soumendra Mahapatra, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - To get a complete overview of the packaging unit
2. Discussion -
(a) Introduction to the Packaging
(b) 17 different production lines
3.Action -
(a)
-> Packing is the step prior to the shipment. It could either be packed as a strip pack, blister pack, in
bottles
or as saches
-> Depending on the customer requirements and the buisness strategy the lines were either automatic
or
manual
(b) There are 17 different production lines dedicated to the packing of different drugs depending on the
requirements and the customer needs
Eg: Production line 17 is responsible for the manufacture of a specific type of medicine known as
Combivir(antiviral medication containing lamivudine and zidovudine) and is packaged as follows:
* The line uses a machine manufactured by the name CAM - it is of Italian origin and is able to
pack at a rate of 300 packs/minut

* The packs are filled with cavities as per the tavlet dimesnions such as size, length and depth
* The next step invlolves the simultaneous packing and covering of the tablets by PVC(Poly Vinyl
Chloride) and Aluminium foil respectively
* It is now sent to a sealing station
* The individual packs are cut as per the requirements
* A stacking bucket stacks the packs and sends them for carton packing
* The inner carton along with the Patent Information Slip(PIS) is folded
* Next, a 2 way barcode scanner, scans the pharmacode on the slip and cross-checks it to ensure
that the correct tablet is being packed
* A weighing control check is performed to ensure that the correct amount of tablets have been
filled in each pack - if any anomaly is found, it is sent to the rejection bin
* The packs are then sealed with cellotape and are filled into larger cartons
* These cartons are then filled into cardboard boxes as per the customer requirements
* The products are now ready to be dispatched
Puneet Chadha
Kavita Tirumale
______________________________________________________________________________
MEETING MINUTES & SUMMARY-DAY 19&20
Purpose of Meeting: Overview of Operational Excellence (Ops Excellence)
Members Present: Srinivas Rao D,
Kavita Tirumale, Puneet Chadha

1. Agenda/Topic - Overview of the Ops Excellence department and the functioning of the Supply Chain
Management (SCM)
2. Discussion -
(a) SCM
(b) Ops Excellence
3.Action -
(a) SCM deals with the following types of planning :-
(i) Demand Planning - As per customers needs
(ii) Material Planning - Done to ensure availability of the materials
-> Raw Material(RM) Planning
-> Packing Materials(PM) Planning
(iii) Capacity Planning - Done to ensure space for the storage of materials
(iv) Inventory Planning - Done to ensure the check on the above three departments
* The planning is done on a timely basis in the following flow:
Annual Planning --> Quarterly Planning --> Monthly Planning --> Weekly Planning --> Daily Planning
* This is done to ensure a comapatibility of the production at a large scale (yearly) as well as on a
small scale (weekly, daily)
(b) Ops Excellence
* The function of this department is to formulate possible methods of improvement of the production
lines - this could be for the warehouse departments or even the production lines for soft gel capsules

* The team takes a parameter for testing and formulates methods to increase the efficiency of the
process
* The most efficient process(w.r.t quanitity) need not be the one that gives optimum quality and thus
the process that ensures both must be formulated
* STRIDES has been in the process of formulating a strategy to integrate all the documentation
systems into an electronic system (soft copy) so that there is no scope for forgery of documents
Puneet Chadha
Kavita Tirumale
______________________________________________________________________________
Purpose of Meeting: Overview of the Facilities and Engineering Department
Date/ Time: 22nd June, 2015/9:00am
Members Present:
Mr. Hafeezur Rehman, Kavita Tirumale, Puneet Chadha
1. Agenda/Topic - Detailed overview on the Facilities and Engineering department and its role in the
functioning of the company
2. Discussion -
(a) 5 teams comprise the Facilities and Engineering department:-
(i) Project
(ii) Engineering and Manintainance
(iii) Facility Upkeep

(iv) EHS (Environment Health and Safety)
(b) Activities performed
3.Action -
(a) 5 teams:
(i) Projects - Assigning and allotment of projects
(ii)Engineering and Manitainance deals with the purchase and maintainance of the
machinery/equipment used in the production floor. The process invloves the assessment and analysis of
the machines and the purchase of the one that gives maximum efficiency and quality
Eg: The compression machines used in the tablet production are state of the art and top of the class
with a production capacity of nearly 50,00,000 (50 lakh) tablets per day
(iii) Facility Upkeep deals with the regular checks (internal audits) of the machinery to ensure a
working standard of the equipments w.r.t quality anf efficiency
(iv) STRIDES has ISO certification for the environmental and safety guidelines and follows a standard of
environmental safety while disposal of waste. The company has also adopted various strategies for the
management of waste
(b) Activities :-
(i) Availability of all equipments at all times
(ii) Run plant in the alloted budget as per decided earlier
(iii) Adhering to the appropriate Building, Manitainance and Documentation practices
(iv) Projects to be pursued and their planning and approval
Eg: Expansion projects
Puneet Chadha
Kavita Tirumale

______________________________________________________________________________

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