Professional Documents
Culture Documents
Induction Module
Induction Module
Contents
• Introduction of Organization
• Quality Management System, Quality policy
• Plant Description (Capacity of the plant. Etc)
• Major Clients
• Code of Conduct
* Scope of Service
* Liability to abide the rules and orders
* Security and Confidential Information
* Personal Favor
* Private trade of employment
* Responsibility to take proper care of machines & Equipment's
* Inspection and searches
* Maintaining Alcohol/Drug free Environment
* Insubordination
* Use of Music at work place
Format No.: QA/078/F/02-00
WINDLAS HEALTHCARE (P) LTD.
Training Module No. : TRG/MOD/014-00 Slide No. 3
Contents
* Safety , Health and Environment Policy
* Email, Internet, Telephone and computer use guidelines
* Use of mobile phone in manufacturing plant
* Meeting with outsiders (Visitors)
* Harassment/Victimization Policy
* Management Staff to promote Company’s Interest
* Other Misconducts
• Service Rules
* Late Attendance
* Gate Pass
* Attendance
* Absence from duty
Training and Development
Contents
• Employee benefits and Welfare Policies
* Leave Policy (National & Festival Holiday/CL/SL/EL Leaves)
* Leave Without Pay
* Procedure of taking Leave
* Employee Provident Fund Benefit
* ESIC Benefit
* Gratuity Benefit
* Accident & Health Insurance Policy for employees
Introduction of Organization
Windlas group has two manufacturing facilities in Dehradun. First manufacturing facility is named “Windlas Biotech Limited” was started
in year 2001 to cater the domestic market. After establishing the first facility management of Windlas group has decided to start next
facility named “Windlas Healthcare (P) Ltd.” to cater regulatory market in year 2008 . Windlas Healthcare is a closely held,
professionally managed, Pharmaceutical Company, established in year 2009 for manufacturing of drug products. This manufacturing facility
is built as per cGMP norms of USFDA, MHRA, EMEA and MCC regulations. It is a flagship company of Windlass group built to cater
customers of domestic and regulated market.
• Plant commissioned and license to manufacture Tablets, Capsules and Dry powder sachets of general category — March 2010
• Inspected and approved by health regulatory authorities -
• USFDA: 2014 &2016 (DUNS # 862102160 ; FEI # 3005339091)
• Ivory Coast: 2012
• Ukraine : 2012, 2014
• Kenya: 2013
• Uganda – 2014
• Malawi - 2014
• Currently shipping products to India, Myanmar, Ukraine, Vietnam
Plant is situated in Dehradun, capital of the Uttarakhand state of India.
Dehradun is Lush green Valley located in foot hills of Himalayas.
Min. temp. during winter ~ 5⁰C
Max. temp. during summer ~ 37⁰C
Easy to approach and well connected by all modes of transport.
By Road 236 Km from New Delhi
Airport (Domestic) : 40 Km
Railway Station : 6 Km
Bus stand : 3 Km
Hospital : 2 Km
Fire Station : 5 Km
Leadership
Chairman
Mr. Ashok K. Windlass
B.E - Civil Engineering
41 Years of entrepreneurial experience
Managing Director
Mr. Hitesh Windlass
MBA in Finance and Entrepreneurship, University of Chicago, Chicago, USA;
MS in Materials Science and Engg, Georgia Tech, USA;
B.Tech, Institute of Tech – B.H.U. Varanasi
16 Years of experience in technology development, marketing and finance
Owner of 14 inventions and 8 US patents
TRAINING
Quality Head
MODULE FOR : INDUCTIO MODULE
Mr.Jaswant Singh
TRAINING MODULE NO.
M.Sc. Organic Chemistry : TRG/MOD/014-00
14 Years Experience
EFFECTIVE DATE :
Quality Head
Mr. Kailash Badoni
MBA in Finance –NIM Mumbai
18 Years Experience
“Quality Policy”
TRAINING MODULE
“To Become a Quality Product Leader in National FOR : Pharmaceutical
and International INDUCTION Industries MODULE
TRAINING
By Continual ImprovementMODULE
of Quality ManagementNO. : TRG/MOD/014-00
System, and Consistently Meeting the
EFFECTIVE DATE
Regulatory Requirement and Customers Satisfaction”
:
“Quality Objectives”
At Windlas Healthcare Quality objective is defined as all pharmaceutical product must be manufactured with assurance that they are fir for
their intended use, comply with the requirement of the regulatory agencies, customers & patients comfort with adequate safety, quality and
efficacy. The attainment of this quality objective is the responsibility of Windlas technical staff and management and requires the
participation and commitment by staff in many different department and at all levels within the company and by the company’s suppliers
To achieve the quality objective reliably there is a comprehensively designed and correctly implemented system of Quality Assurance
Incorporating Good Manufacturing Practice and thus Quality Control. It is fully documented and its effectiveness monitored. All parts of the
Quality Assurance systems are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and
facilities .Quality is built by design and development into the product and QMS is continuously evaluated to achieve the quality, safety and
Plant Description
Total Area of Site 5872 m2
Warehouse 1982.1 m2
Administration 223.4 m2
Designed as per international cGMP norms for manufacturing of general categories pharmaceutical products.
Major Utilities: - Purified Water System, HVAC, Compressed air, ETP, Boiler, Chiller, DG set
All critical utilities are qualified as per cGEP and pharmaceutical requirements.
All equipments and critical instruments and gauges calibrated periodically as per defined frequency and preventive maintenance is
All maintenance, calibration, usage and cleaning activities are recorded & verified.
All core manufacturing areas are having dedicated HVAC systems & classified as Class 100,000 (ISO 8) & are provided with HVAC
systems having terminal HEPA filters - EU13 (0.3µ, efficiency 99.97%) for the environmental control. (Filtration Level is EU-04, EU-
06, EU-09 and EU-13 filters (HEPA) corresponding to 10, 5, 1 & 0.3µ respectively.
All HVAC’s are qualified as per ISO 14644-1 guideline and records are maintained thereof .
Purified water pipelines and vessels are made-up of SS316 with Electro polished. All
joints are connected with orbital welding.
Micron filters are installed of 10µ and 5µ made up of PTFE (Poly Tetra Fluoro
Ethylene) and hydrophobic in nature.
Vent filters (0.22 µ) are installed on water storage vessels made up of PTFE
hydrophobic in nature.
Purified water is stored in 3000 Liter storage vessel made up of SS316 which always
remains in continuous recirculation.
Sanitization of purified water storage tank & piping is done fortnightly with Hot
water of 85 °C.
HVAC
0.3 µ (99.97% efficiency) 37
(EU-04- 10µ, EU-06 -5µ, EU-09 - 1µ & EU-13 - 0.3µ)
Chiller 283 TR 02
UPS 42 AH 03
Separate secondary change rooms for core manufacturing area & packaging.
Epoxy flooring – Core manufacturing & primary packaging area.
PU painted walls and covings.
Powder coated door panels.
Access control system and color coded gowns.
Separate day stores based on processing status including RM Day store, Primary PM Day store, In-process quarantine (Blend,
filled EHG capsule, compressed tablets, coated tablets and ready to pack filled EHG capsules and coated and compressed tablets).
All equipment of GMP model with SS316L (contact parts).
Separate areas for equipment cleaning and storage.
Temperature and RH controlled between NMT 25 deg C & NMT 60% respectively with dedicated AHU’s in individual cubicles.
Coating (2 areas) – Equipped with Auto coater with solution preparation tank & Coating Area 1:10.0 to 100 kgs
solution preparation tank Area 2:200.0 to 350.0 kgs
Note :-Also depend on bulk density of raw material
Capsules (1 area) Semi-automatic filling machine :20000 Capsule /hrs
Equipped with Automatic capsule filling machine with online polishing, sorting & Automatic capsule filling machine :40000 Capsule /hrs
weighing. Facility for pellet and tablet filling & Semi –automatic capsule filling machine
Packaging (6 lines) Alu-PVC Blister: 0.66 million tablets
1 Alu-Alu Blister: 1 million tablets
Sachet Filling & Sealing: 0.06 million
1.Bottle Filling: 60 BPM
2.Bottel filling ;up to 120 BPM
Quality control lab is provided with modern sophisticated, analytical instruments like HPLC, GC, IR, UV, AAS, Dissolutions
Apparatus etc. required for analysis of raw, packaging & finished products which are maintained as per cGLP and Pharmacopoeial
requirements.
In-House calibration of all instruments.
Availability of reference standards, qualified working standards, media and certified microbial cultures for analysis.
Separate area for handling of hazardous chemicals with fume Hood.
Separate chemical analysis and hot zone.
Personnel entering in Quality Control lab shall wear personnel protective clothing and PPE
Microbiology Lab
Equipped with Autoclave, Incubators, Laminar Air Flow, Air Sampler, pH meter, Analytical balance, Sterile Dress Cabinet and Fogger
International Business
In the international markets, we operate through two models –
1. Our Own Brands
2. Products & CMO work
Below is a snapshot of our product and service offerings across different parts of the world.
USA
Windlas Healthcare is focused primarily on developed markets, and USA is the highest priority market. We have already secured US
FDA approval in 2014 we were audited again in 2016. We have already filed 4 ANDAs in USA in 2014 and aim to file 5-7 ANDAs
each year.
Our focus for US is defined by working on highly differentiated, difficult to manufacture niche products.
Besides that, we also seek CMO projects for US and other regulated markets.
Licensed by State FDA, for manufacturing of for general category of Tablets, Hard Gelatin Capsules & Dry Powder
(Sachets).
The Manufacturing License Numbers: 47/UA/2009 & 60/UA/SC/P-2009 is valid till 11/03/2020.
To become a quality product leader in national and international pharmaceutical industry by continual improvement of quality
management system and consistently meeting the regulatory requirements and customer satisfaction.
Windlas Healthcare Private Limited is committed to continuous review and evaluation of its quality Management system to ensure
Product Quality by Design and Development as per current regulatory requirements and cGMP standards.
At Windlass, quality is a part of our DNA, and therefore, this mindset is visible in each of our thoughts and actions. This attribute has
enabled us to secure a place for ourselves in the global market today. A drug or formulation must adhere to numerous parameters to be
able clear the stipulated quality standards necessary for export and marketing. A number of stringent analysis and tests that are
conducted at our organization determine these.
Major Clients
Code of Conduct
Objective:
The company expects that all employees conduct them in a manner which promotes efficient and smooth running of the organization.
The following represents the code of conduct.
Scope of Service:
Unless otherwise distinctly provided, the whole time of an employee shall be at the disposal of the company and he/she shall serve the
company in its business in such capacity and such place as he/she may, from time to time be directed.
Personal Favor:
No employee shall use his position or influence directly to secure any favor from any concern or individual with which the company has
business dealing.
Private Trade of employment :
No employee of the company shall except with prior permission of management shall engage themselves directly or indirectly in any trade ,
business or undertake any other employment.
Exit search: Inspection or searches for prohibited material like alcohol, firearms explosive, any illegal drugs etc. and company property may be
conducted at any time of any employee at location where employees enter and exit Windlas healthcare premises.
To ensure the safe and efficient working environment no employee will enter/remain in the premises of company while under the influence of
intoxicating drinks or drugs.
To prevent the presence of drugs or alcohol in the workplace Windlas healthcare reserve a right to take disciplinary action against any employee,
found committing any of following act.
a. The use, possession, purchase, sale, manufacture, distribution, dispensation etc of illegal drugs on Windlas healthcare premises.
b. Reporting to work under the influence of alcohol or illegal drugs.
Insubordination:
Refusal to follow direction/instruction of superior will be constructed as insubordination and shall be liable for disciplinary action.
Safety:
All employee of the company shall follow the safety guidelines, instructions including the fire prevention instructions, and shall
take necessary precaution in the use of chemicals etc. Any breach in such instruction shall make employee liable for the disciplinary
action.
i. Use of computer or telephonic equipment or any other communication devices is not private or confidential and personal use of
these devices is strictly prohibited.
ii. Windlas Healthcare reserve the right to search, intercept and review both incoming and outgoing communication and all device
information including any password protected employee communication.
iii.Inappropriate use of the communication devices is misconduct and may result in disciplinary action.
Harassment/victimization of Employee:
Windlas healthcare is committed to providing a workplace free of sexual as well as other harassment based on the factor such as
sex, race ,color, religion , national origin, age , marital status, disability etc.
Other Misconduct:
Besides the violation of the above mentioned guidelines, the following behaviors of an employee shall be come under the
definition of misconduct and is liable for disciplinary action.
* Failure to observe safety instructions, unauthorized removal, interference or damage to machinary guards, fencing and other
safety devices.
* Refusing to accept warning, suspension orders etc.
* Committing other offences regarding property within the meaning of the indian penal code.
* Striking work or adopting go slow methods, either single or along with others in contravention of these standing orders or any
statute, law , rule, enactment, agreement, memorandum of settlement agreed from time to time and for the time being in force.
* Theft, fraud or dishonesty in connection with the employer’s business property.
* Habitual negligence or neglect of work.
* Indiscipline, breach of any rules of instruction for the maintenance and/or instructions for the running of any department or
maintaining its cleanliness.
* Refusal to work in any other shift.
* Refusal to be searched by security staff or anybody else so authorized by management.
* Refusal to sign any form document , or register kept or maintained for the purpose of maintaining daily records of either
production or details of any goods lost or damaged etc.
* Refusal to perform over-time or to move to another shift or proceeding on outstation duties or to carry out any duty assigned at
any other place or refusal to carry out an order of transfer.
* Using abusive language or slogans against any superior officer or any other employee of industrial establishment.
Service Rules
Late Attendance
Gate Pass
Attendance
Absence from Duty
Service Rule:
These rules have been framed to maintain minimum standards of discipline which are applicable equally at all levels. Allowance of
any deviation is strictly at management discretion.
Late Attendance:
An employee reporting late on duty shall be recorded in the computerized attendance record system. Individual arriving after five
minutes of commencement of shift hours shall be treated as late, reporting for three ocassion/day in a month by an employee shall
make him/her liable for half day deduction of leave or salary in lieu thereof. Any repetition after three times in a month shall also be
make the employee liable for disciplinary action.
Gate Pass :
Any employee leaving the office place during the working hours or leaving office early on official or personal worl shall fill in the
prescribed gate pass format and get same approved from the appropriate authority/HOD. The duly approved gate pass shall be
submitted at security office at the time of leaving factory.
Attendance:
Every employee shall personally mark his/her attendance on the computerized attendance record system by putting scan his/her
finger in the attendance machine. Any employee does not record or punch his/her attendance shall be deemed to be absent from
his/her duty unless an adequate reason of failure to mark his/her attendance is accepted by the authority designated for the purpose
For the development of competence of its employees Windlas healthcare provides continuous training to its employees following
are the procedure of training at Windlas healthcare.
i. In-House Training : The concerned H.O.D shall identify the training need for employees of its department and H.R Department
shall arrange in house training programmes as per the training needs. These training shall be based on the required skill &
behaviours, for performing job.
ii.Out sides Training :Where the company thinks that in house training programmes are not adequate to meets the employees
training needs employees shall also be sent for attending training programs organized by the outside professional or bodies. These
programmes shall not only be helpful in improving employees abilities to perform better in their present assignment, but also
provides a means of self improvements.
Leave Policies:
Leave & Holidays:
The leave year for all type of leave & holidays shall be the calendar year i.e. from January to December. No employee
shall extend his/her leave beyond the sanctioned period without receiving prior approval in writing.
2.Casual Leave:
All employees shall be entitled for seven days casual leave in a leave year subject to the general condition mentioned
below:
a. Casual leave shall be credited to an employee’s account on first day of January every year or prorate basis if joining
falls within
the year.
b. Granting of leave is not automatic and is at the management, sole discretion
c. Prior approval of leave is essential If because of unavoidable circumstances prior approval has not been obtained, it will be
essential for the employee to inform his superior through telephone about his inability to attend office. Subsequent written
approval has to be obtained within two days of expiry of the leave availed.
d.Casual leave cannot be combined with any other type of leave this may be suffixed or prefixed with holiday/weekly off day but
not both. Weekly or other holidays falling within the casual leave shall be counted as leave.
Casual leave for a less than half day or exceeding three days at a time shall not be granted.
3.Sick Leave:
The employees not covered under E.S.I. Act shall be entitled for 10 days sick leave for every calendar year of services.
a. Sick leave can be accumulated up to maximum of 24 days.
b.For Sick leave exceeding two days certificate from the recognized medical practitioner, Approved by the company shall be
provided.
c.Where sick leave exceeds 05 days management has the right to get the employee examined by a doctor appointed by the
company.
4.Earned Leave:
All Staff member i.e. from Tr. Chemist to above shall be eligible for earned leave on the basis one day leave for every 15 days work
during the previous calendar year, subject to employee has worked for a continuous period of 305 days in the preceding calendar
year.
a. All workmen shall be eligible for earned leave on the basis one day leave for every 20 days work during the previous calendar
year, subject to employee has worked for a continuous period of 305 days in the preceding calendar year.
b.An employee, whose service commences in the middle of preceding calendar year shall be eligible earned leave calculated on
prorate basis.
c. In calculating of earned leave a period of half day or more shall be treated as one full day and a period less than halfway shall be
omitted.
d. Earned leave may be accumulated up to maximum of 90 days.
d. Earned may be encased subject to sole discretion of management and the following guidelines.
E.S.I. Benefit:
All employee of the company getting Rs. 21,000 & below as gross salary shall be eligible for E.S.I. scheme.
Benefits:
i.Medical benefit for self, spouse & children & parents (if dependents)
ii.Leave benefit during sickness/maternity
iii.Compensation for Partial/ total Permanent or temporary disablement/ death due to employment
injury
iv. Maternity benefits to insured women.
Gratuity Benefit
Gratuity Benefit :
An employee who has completed 05 years of continuous services shall be eligible for the payment
of gratuity @ rate of 15 days basic salary for each completed year of services subject to the
maximum limit of Rs.1000000/-. The gratuity benefit is linked with LIC Scheme and more
benefits shall be paid to the family or nominee of the employee, in case of unfortunate event of
death of employee while in the services in the company.
ii.Under the policy accident means a sudden, unforeseen, uncontrollable and unexpected physical event to the insured person
caused by external violent and visible means occurring in side as well as outside the factory premises
iii. The cover is for 24 hours and worldwide basis.
Benefit:-
Table-A: Under the table –An only accidental death is covered. i.e. if an insured person died due to the accident policy period the
insurance company will pay an amount equal to sum insured as mentioned in table- A, to the nominee of insured person.
Table –B: If an insured persons suffer from any of the following bodily injury during the policy period. The insurance company
shall pay the compensation amount as per the norms laid down by insurance company, subject to the maximum limit of sum insured
as mentioned in Table -B
. a. Loss of limbs.
b. Loss of eyes.
c. Permanent Total disablement.
d. Permanent partial disablement.
Policy coverage:
During the policy period if any insured person shall contract any disease or sustain any bodily injury through accident and insured
person is required admission in a Hospital/Nursing Home for minimum of 24 hrs upon the advice of medical practitioner. The
insurance company will pay to the insured person, the amount of such expenses as area reasonably and necessarily be incurred by
the insured person but not exceed the sum insured i.e. Rs. One Lac only.
Exclusions:
The insurance company shall not be liable to make any payment under the policy in respect of any expenses whatsoever incurred by
the insured person due
i. Any disease which is pre existing at the time of proposing this insurances.
ii.Any disease other than exclusive disease, contracted by the insured person during the first 30 days from the commencement date
of the policy.