What are the contents of Annual product quality review (APQR)?

Contents of an APQR is:

1.       Introduction

2.       Number of Intermediates and APIs batches produced

3.       Review of output for all Isolated Intermediates and Finished Products

4.       Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products

5.       Summary of changes made during the year with respect to equipment, Process, Specifications, and Methods, Raw materials and others.

6.       List of Deviations and a brief description of deviations and action taken.

7.        List of customer complaints; Return goods and Recalled goods along with description and actions are taken.

8.       Number of Reprocessed and Reworks batches in all stages during the year-2009

9.        Review of Key starting materials and Primary packing materials and Rejections.

10.   Review of Bioburden on the product (for a minimum of 3 batches)

11.   Review on Stability studies and Summary

12.    List of Out of specifications for Finished products

13.   Review of Retained samples quality (Finished product)

14.   Review of Validation packages (Process, Equipment, Procedure)

15.   Status of Drug Master File (if any), Drug Master File new updates

16.    Details of special training provided to employees in case of Deviations or Complaints received regarding a particular product

17.   Summary Report

What are the different types of safety factors used in the pharmaceutical industries?

Following safety factors are used in pharmaceutical manufacturing.

•  1/10 to 1/100th of a normal daily dose = Topical products

•  1/100 to 1/1000th of a normal daily dose =     Oral products

• 1/1000 to 1/10000th of a normal daily dose = Injectable & Ophthalmic products

• 1/10000 to 1/100000th of a normal daily dose = Research, investigational products.

What is the solubility data as per any Pharmacopoeia?

Different products have different solubility levels. The solubility of the product is determined by dissolving in know volume of solvent.

•  Approximately volume of solvent in ml per gram of solute at 20° to 30°C
• Very soluble : Less than 1
• Freely soluble : From 1 to 10
• Soluble : From 10 to 30
• Sparingly soluble : From 30 to 100
•  Slightly soluble : From 100 to 1000
•  Very slightly soluble : From 1000 to 10000
• Insoluble / practically soluble : More than 10000

 Example:  Very soluble means one gram of solute substance will require less than 1 ml of solvent.

What is the necessity of analytical method validation?

The principle purpose of analytical validation is to ensure that a selected analytical procedure will give reproducible and reliable results that are adequate for the intended purpose. It is thus necessary to define properly both the conditions in which the procedure is to be used & the purpose for which it is intended.

 It means that analytical method validation is to prove that the analytical method used for analysis of the product works perfectly.

Define Bio burden?

The level & type (i.e. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

 It means the bioburden is the number microbes present in the raw material or water sample. Bioburden does not claim any specific microorganism.

Describe the method of testing for checking of MOC of SS material (Molybdenum test)?

Procedure:

1.   Put one drop of the electrolyte solution of molybdenum test kit on the clean metal surface, which is to be tested.

2.       Switch on the detector and touch the metal tip of the detector on the metal surface & carbon point in the electrolyte solution.

3.       Do not pass the current for more than 3 to 4 seconds.

4.       If the red color appears and is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-316.

5.       If the solution remains colorless or green color appears then it can be concluded that MOC of the part being tested is SS-304.

6.       If the black color appears & is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-302.

What are the test parameters in the nitrogen gas validation?

Test parameters during validation and its frequency are given below:

a) Test for oil mists - Every 6 months once

 b) Test for moisture content - Every 6 months once

c) Particulate count (Non-viable) - Every 6 months once

d) Sterility test (Aseptic area locations) - Every 6 months once

e) Bioburden test (Controlled area locations) - Every 6 months once

The purity of nitrogen gas (Based on manufacturer COA)

 * Perform the nitrogen gas sampling & testing for three consecutive days.

What do you mean by Critical Quality Attributes?

A critical quality attributes is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

It defines that critical quality attribute is to maintain the product quality within the predefined limits.

What are the possible reasons for the Non-conformities?

Non-conformities are the deviations from the predefined standards. Generally, these are findings in a requlatory audit.

 The following are the possible reasons, but not limited:

·         Management attitude

·         Ineffective documentation

·         Lack of trained personnel

·         Lack of co-ordination/ co-operation within or among departments.

What are the types of DMF?

Drug master files are regulatory submission requirements.

There are four types of DMF. They are referred to by their numbers in Roman numerals:

Type-I: Is an obsolete number once used for a category that no longer exists because it was found to easily fit into and overlap with the other four categories.

 Type-II: DMF is for companies who supply drug substances, drug products, intermediates & material used in their manufacture.

Type-III: DMF is for companies who supply packaging (container closure system) for human drugs & biologics.

Type-IV: DMF is for companies who supply excipients

Type-V: DMF is for companies who supply clinical services, sterile manufacturing etc.

What is a DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

A DMF is a package of proprietary information filed voluntarily by a company with the FDA. If it held by them in confidential closed files until such time as an FDA reviewer requests a review of the DMF.

What are the different climate zones in the world?

Different zones of the world have different climatic conditions. The world is divided into the five climate zones and is given :

Zone	Name	Conditions
I	Temperate	21° C / 45% RH
II	Subtropical & Mediterranean	25° C / 60% RH
III	Hot & Dry	30° C / 35% RH
IV A	Hot & Humid	30° C / 65% RH
VB	Hot & Very Humid	30° C / 75% RH

What are the advantages of Rinse sampling?

Rinse samples are taken during the cleaning of the equipment. A large surface area of the equipment can be sampled using this technique.

Following are some advantages of rinse sampling.

• ·         Adaptable to online monitoring
• ·         Easy to sample
• ·          Non-intrusive
• ·          Less technique dependent that swab
• ·         Applicable for active, cleaning agents & excipients allow sampling of large surfaces
• ·         Allows sampling of unique (e.g. porous) surface.

What are the advantages of Swab sampling?

Swab samples are taken from equipment as well as other areas. It is useful to take a sample of sticky material.

 Following are some advantages of this sampling technique.

• ·         Dissolves & physically removes a sample
• ·         Adaptable to a wide variety of surfaces
• ·         Economical & widely available
• ·         May allow sampling of a defined area
• ·         Applicable to active, microbial & cleaning agent residues.

What is commissioning?

Commissioning is an engineering term that covers all aspects of bringing a system /sub-system to a position where it is regarded as being ready for use in pharmaceutical manufacture. Commissioning involves all the basic requirements of Installation qualification (IQ) & Operational Qualification (OQ).

In simple words, commissioning is the process to start a system from its initial stage to the working stage where the system is ready to work.

What is the difference between controlled copy and un-controlled copy?

Controlled copy: A controlled copy is a formal copy of the latest, correct issue of a document; an identified issue of a document to an individual or location of the record. The controlled copy is officially tracked, updated & destroyed to assure that it is current.

Uncontrolled copy: An informal copy of a document for which no attempt is made to update if after distribution; the document is marked “uncontrolled” and the user determines if the document is active prior to use. Controlled and uncontrolled copies of the documents are issued by the quality assurance department as per the official requirements. Uncontrolled copies are unofficial copies of documents generally, issued for review purpose.

What do you mean by re-validation?

A repeat of the process validation to provide an assurance that changes in the process/ equipment introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

 Revalidation is to validate any process or equipment again after the maintenance or change that can affect the quality of the product. It ensures that the system or equipment is working as per the standards.

What are the possible causes for “Out of Specification”?

 Out of specification is the deviation of the product from the pre-determined specification.

The following are the possible causes for out of specification:

• ·         Test analysis error in QC Lab.
• ·          Lab equipment malfunctioning or off-calibrated
• ·         Production equipment malfunctioning or off-calibrated
• ·         Operator/human errors

What is the difference between specification and Limit?

Specification: A document giving a description of a starting material, packaging material, intermediate, bulk or finished product in terms of its chemical, physical & possibly biological characteristics. A specification normally includes description clauses & numerical clauses, the latter stating standards & permitted tolerances.

Or

 It is the type of standard which is often referenced by a contract or procurement document. It provides the necessary details about the specific requirements.

 Or

 Lists of detailed requirements with which the products/ materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.

Limit: The point, edge or line beyond which something cannot or may not be proceeding. The boundary surrounding a specific area, bounds.

Describe about swab and rinse sampling?

What do you mean by “performance qualification

How many phases are in performance qualification of purified water system?

What are the types of non-compliances in the internal audit?

Describe the categories of the market complaints

What do you mean by “Reference standard” and “Working standard

Define stability study and its necessity?

Stability study is defined as “stability testing is to provide evidence how quality of product varies with time under influence of temperature, humidity & light”.

Stability study is essential because it helps to:

·         Establish a re-test period for drug substance 

·         Establish a shelf life for drug product

·         Recommend storage conditions for products

What precautions are to be observed while working in the powder processing room?

 Following precautions should be observed while working in the powder processing rooms:

·         Absolute discipline w.r.t complete uniform

·         Bunny suit, clean shoe covers, hand loves, snoot mask etc. and SOPs compliance

·         Positive pressure in the area

·         Housekeeping in the area Avoid foreign objects (pens, pencils, tools etc.)

·          Identification / status card on materials

·         Stage slips on equipment

·          Adequate Temperature (less than 25°C)

·         Avoid extraneous contamination from dust, insects, micro-organism, foreign particles etc.

·          Check the condition of sieves used in multi mill and sifter

·         Cleaning and calibration of weighing balances

·          Usage of fresh, clean drums and poly bags for the final packing of the product.

What is in-process control?

What are cGMP requirements for building and facilities?

 Following are the cGMP requirements for building and facilities:

• ·         Suitable size, construction and location of the facility
• ·          Facilitate cleaning, maintenance and proper operation
• ·         Adequate space for manufacturing and storage
• ·         Defined areas of adequate size for all activities
• ·         Water supply: continuous and of good quality of purified water or WFI
• ·         Power supply: continuous and uninterrupted power supply
• ·         Adequate lighting, ventilation, air filtration, plumbing sewage, toilet facilities.

What is mean by “Clean-in-Place” and “Clean-out-Place”?

What is the difference between dedicated and non-dedicated equipment?

What parameters considered during performance qualification of HVAC?

What are the sampling techniques used in the cleaning validation?

What do you mean by reconciliation?

What is Master validation Plan (VMP)?

What do you mean by product recall?

What do you mean by residual solvent?

What will happen if cGMP are not followed?

What is retention sample & why retention sample is preserved?

What is As-built clean room (facility)?

What is At-rest clean room (facility)?

What is Operational clean room (facility)?

Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation?

What is the efficiency of the High Efficiency Particulate Air (HEPA) filter?

What What is the maximum time allowed after cleaning with water as the last rinse?

What is calibration?

What is room temperature?

Why one liter of water is equivalent to one kilogram of water at room temperature?

5 Tips for Interview in Pharmaceuticals

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Tips for Telephonic Interview.

Top 10 interview Questions.

Cadila Pharmaceuticals Ltd - Walk-In Drive for Multiple Positions on 22nd December 2018

Dear Candidate,
Greetings of the day!! 
Cadila Pharmaceuticals Ltd. is conducting a Walk-In Drive to fulfill the technical requirements at Plant based at Dholka (Gujarat).
Walk-In Detail for 22.12.18 (Saturday) at Dholka Location. 

·         Address : Survey No 1389, Trasad Road, Dholka, Gujarat 382225

·         Time : 9 AM to 4 PM

·         Contact : Plant HR

Position Details :  

·         Clinical Data Management:- M.Pharm / M.Sc / Computer science graduate with 2 to 5 yrs working experience in Clinical data management, Query resolution, Discrepancy Management in EDC, Paper based studies , Preparing of data entry guidelines, self Evident correction convention (SECC), final QC report, DMP (Data Management Plan).

·         Biostatistician:- M.sc (Stat) / M. Pharm (with certificate course of biostatistics) having 2 to 5 yrs of experience in Providing Statistical inputs to BE protocol, Clinical trial Design, Sample size calculation. Generation of Randomization schedule, tables and listing. Responsible for Pharmacokinetic and statistical analysis for BA/BE, clinical trials and pre-clinical studies. 

·         Data Programmer:- M.Pharm / M.Sc / Post graduate in computer science with 2 to 5 years working experience in Preparation of data management plan, Preparation of annotated CRF, Database design, Edit Check programming. Preparation data validation documents for EDC and paper based studies, Generate data extract views. Perform critical and final data QC activities.

·         Doctor :- MBBS / MD, Experience with 2 to 4 years. Responsible for adherence to ICH GCP and conduct of the studies as per ICMR guidelines for ethical conduct of biomedical research involving human subjects. To work as clinical/ principal investigator for BA/BE, clinical trials and PK studies. 

·         Study Coordinator:- M.Pharma / M.sc, Experience:- 1 to 4 years. Reviewing of protocol and informed consent from for BA/BE study. Managing and submission of study documents to independent ethics committee(IEC). Registration and screening of the volunteers. Monitoring BE study. Review of Clinical study report. Also to work as deputy pharmacist.

·         CRA:- M.Pharma / M.sc with 2 to 6 years of experience Co ordinate to sites for IEC regarding study related required approval and notifications. Charting of site initiation, monitoring plan. Drafting of budget and plan for whole projects in tentative amount of laboratories, sites, printing of documents, submissions etc. Periodic monitoring to various sites. Co ordinate with the ethics committees.

·         QA:- M.Pharma / M.sc, Experience:- 2 to 6 years. Experience of Issuing controlled / documents, and approved uncontrolled / usage copies of SOPs, forms / formats / logbooks, study documents of CRO. Issuing controlled / documents, and approved uncontrolled / usage copies of SOPs, forms / formats / logbooks, study documents of CRO. 

Walk-In for Chemist / Jr. Chemist / Sr. Chemist / Technician / Sr. Technician on 22nd December 2018 @ Sri Krishna Pharmaceuticals

Hiring M.Pharmacy (Pharmaceutics) Freshers @ HETERO DRUGS LIMITED

Greetings from Hetero!!!

We have openings for Technology Transfer Department for M.Pharmacy (Pharmaceutics) Freshers.

Interested Candidates can mail to arunkumar.k@heterodrugs.com

Regards

Hetero HR

LUPIN PHARMA - Urgent Vacancy for IPQA-Officer / Electrician for Indore

Urgent Vacancy for IPQA officer

Company: Lupin Pharma

Location: Indore

Qualification: B.Pharm/M.Sc

Experience required: 2-4 year

Interested person may call on 9617770876 or may send resume on sunilnamdev@lupin.com

Require Electrician for Lupin Pharmaceutical Company, Indore Location

Desired skill requires:

- Trouble shooting of LT Electrical installations like chiller, DG circuits and Air compressor.

- Hands on Experience in OSD Granulation, compression and packing area maintenance. Preferably Fette, Kilian compression, Countec, CVC packing, ACG FBEs.

- Exposure in SAP PM module and entries in the SAP after PM.

- Basic knowledge instrumentation and automated installations.

Location : Indore (M.P)

Qualification : ITI / Diploma

Experience  : 3-7 Years

Position : Associate (EA) & Jr. Officer (E0) – Engineering

CTC : 3.0 – 5.0 LPA

Regards,

Sunil Namdev

HR Department

Lupin Ltd

Contact : 9617770876

Email Id: sunilnamdev@lupin.com

Zydus - Walk-Ins for QC / QA / Micro / Analytical Lab / Manufacturing / Packing / Stores / Warehouse / Engineering on 23rd December 2018

Macleods Pharma - Walk-Ins for Freshers & Experienced on 23rd December 2018 @ Panchkula, Haridwar & Sarigam

USV LIMITED - Urgent Openings in QC / Micro / Manufacturing / IPQA & Documentation / Production @ Daman

Opening in USV Pvt. Ltd.– Daman

Send your profiles mentioning position in email subject line for better visibility.

Officer / Senior Officer - Quality Control

Qualification:- B.Sc/M.Sc/M.Pharm/B.Pharm  with minimum 2 years of regulatory experience.

Officer / Senior Officer and Executive - Microbiology

Qualification:- M.Sc micro  with minimum 2 years of regulatory experience.

Operator/Technician-Manufacturing

Qualification:-  HSC/I.T.I./Diploma/BSc with minimum 2 years & above relevant experience of formulation plant. 

Officer /Senior Officer - IPQA and Documentation

Qualification:- B.Sc/M.Sc/M.Pharm/B.Pharm  with minimum  2 years of experience in regulatory company.

Opening for Sterile Production in USV Pvt. Ltd.– Daman

Aseptic Operator/Technician-Manufacturing

Qualification:- /Diploma/B.Sc with minimum 2 years & above relevant experience of formulation plant. 

Officer and Sr. Officer-Sterile Production

Qualification:- M.Pharm/B.Pharm/with minimum 3 years & above relevant experience of formulation plant.

All interested candidates can send their updated CV on ajeet.singh@usv.in sanafatma.khan@usv.in

Kindly mention department and position in subject line of mail for better identification

For any query contact on 0260 6636229/6636232.

Torrent Pharmaceuticals - Walk-In Interviews on 23rd December 2018 for Production / Packing / QC @ Sikkim

Cadila Pharmaceuticals Ltd - Walk-In Interview for Multiple Vacancies on 20th December 2018 for Medical Representatives

SIPRA LABS LIMITED - Walk-In Interviews for Multiple Positions on 22nd December 2018 @ Hyderabad

Acme Pharmaceuticals - Walk-In Interview for Production / Packing / QC / QA / QC-Micro / Warehouse on 22nd December 2018

Dear All,
Acme Pharmaceuticals Pvt Limited (subsidiary of Zydus group ) is engaged in small time exports to the ROW markets and for domestic market.
The Injection site is WHO-GMP approved and registered in Kenya and Mozambique and has been audited by Yemen Health authority.
Greeting from Acme Pharmaceuticals Pvt. Limited (subsidiary of Zydus group ) !!!!
Job opening for Production, Packing, Warehouse, QC/QA/QC Micro Officer / Executive., for Sanad Location 
Department: Production
Post: Officer
Qualification: B. Pharm
Industry:- Pharmaceutical
Experience: 01-02 Years
Vacancy: 2
Department: Packing 
Post: Officer
Qualification: B.Sc / B. Pharm
Industry:- Pharmaceutical
Experience: 01-02 Years
Vacancy: 1
Post: Plant Operator
Qualification: ITI (Operating of Brevity/ Vial washing/ Blister Pkg/ Labeling machine)
Industry:- Pharmaceutical
Experience: 02-03 Years
Vacancy: 8
Department: Warehouse
Post: Officer 
Qualification: B. Com/ B.Sc (Knowledge of computer in SAP for material inward/outward)
Industry:-  Any
Experience: 01-02 Years
Vacancy: 1
Department: QC/QA/QC Micro
Post: Officer/Executive 
Qualification: B. Pharma/ B.Sc/ M. Sc Micro/ M. Pharm QA (Knowledge of HPLC/ QMS/ Documentation/ IPQA/ Microbiology)
Industry:- Pharmaceutical
Experience: 01-04 Years
Vacancy: 5
Interview Venue:

PF 61/62 GIDC Sanand-II,

Opp. Teva Pharma,

Opp. Chharodi Railway Station Sanand,

Ahmedabad

Walk-In Date: 22/12/18 (Saturday) 

Interested candidate can contact on:  6359203037  Or can send CV on: -hr@acmepharma.in / pv.shah@acmepharma.in
{Monday to Saturday- 10:00am to 07:00pm only}

Yours
Pankaj Shah
Team-HR
Acme Pharma

Cognizant - Walk-In Interview for Freshers & Experienced Candidates on 24th December 2018 in Kolkata

Cognizant Kolkata Hiring for Pharmacovigilance Domain
Job Description

·         High affinity to process driven tasks

·         Ability to act in an inter-cultural setting

·         Excellent ability to prioritize tasks, meet deadlines and work under changing conditions and high pressure

·         Concern for training

·         Team player

·         Knowledge of clinical research and Pharmacovigilance processes

·         Serves as first level contact for the in-scope process of the engagement

Other Requirements: 

·         Candidates should be good in communication 

·         Comfortable working in 24/7 shifts.

Role: Trainee Junior Data Analyst (Entry Level) (Non-Voice)
Date: 24th Dec'18 (Monday)
Time: 9 am to 12 noon
Interview Mode: Walk in
Venue: 
Cognizant Technology Solutions
Techno Complex,
Plot GN-34/3,
Sector-V,
Salt lake Electronic Complex,
Kolkata -700091
(Near Ashram Building/ SDF more)
Qualification required: 
B. Pharma / B.Sc. (Nursing) / BHMS
(B.Tech/B.E./BCA /Diploma not eligible)
Work Experience: 0 -12 months (in relevant domain)
Freshers can also apply.
Work Location: Kolkata
Interview Location: Kolkata
Note: 
Candidate have to carry the following documents while coming for the interview:

·         2 updated resumes

·         Valid Govt. photo Id proof