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[pharmatechy]

Quality Control in Pharmaceutical Industry | QC in Pharma Company

The Quality Control department's major and important role is in the Pharmaceutical industry.

The main role of the quality control department in the pharma industry is to check the quality of various products, such as raw materials, in-process samples, and finished products.

Their main agenda is to analyse and control the quality of the products at all stages of the manufacturing of API or Formulations.

QC is done by the Qualitative and Quantitative analysis of specific materials as per Stanard Testing Procedures (STP) or Method of Analysis.

Generally, the QC department is divided into four sections. These are main

Raw Materials

In-process Quality Checks (IPQC)

Finished Products

Stability Studies

Raw materials:

The materials come from outside industries or suppliers and road tankers check the quality of the materials as per in-house specifications or Standard testing procedures. 

These are categorised into four parts.

General Raw materials:

These are some chemical analyses, like titrimetry, and chemical analysis methods, such as organic and inorganic acids, bases, salts, etc.

Ex: Hydrochloric acid(HCl), Sulphuric acid(H2SO4), Nitric acid(HNO3), Caustic soda(NaOH), Sodium carbonate(Na2CO3), Methanol, Toluene, Acetone, Dichloromethane etc…

Key Starting Materials (KSM):

These are the building blocks of drug intermediates or used to form the structure of compounds, APIs, or Drug substances. 

The sampling method is different from general raw materials.

These are analyzed with both chemical and instrumental analysis.

Ex: Speciality Fine Chemicals, Drug Intermediates etc.

Packing Materials:

PM is used for Products/Compound materials that are stored

Ex: Fibre drums, HDPE, LDPE drums, Polyethene bags, etc…

Hazardous Materials:

HM are harmful or affect body raw materials to handling in careful safety precautions and as per its Material Safety Data Sheets (MSDS) so vendors or suppliers give a certificate of analysis based on these are approved as per customer COAs.

Ex: Sodium Hydride(NaH), Sodium Amide(NaNH2), NaCN etc…

Some catalysts are also approved as per customer COAs

Ex: Raney-Nikel, Palladium/Carbon(Pd/C) used for Hydrogenation reaction.

In-Process samples:

Online chemical and instrumental methods analysis as per in-house specification & STPs carried out samples coming from the manufacturing blocks or production department to time to give results after the process continuously.

Finished Products:

Complete Analysis carried out as per customer or In-house or Pharmacopia specification and Standard Testing Procedures of the final products.

The analysis carried out in the Quality control department is divided into two parts. These are

Chemical Analysis Laboratory (Wet Lab)

Volumetric analysis:

Chemical labs have five types of titrimetric analysis

Acid-Base Titration Ex: Hydrochloric acid (HCl), Sodium Hydroxide (NaOH)

Argentometric titration Ex: Sodium Chloride(NaCl), Aluminum chloride (AlCl3)

Redox Titration Ex: Sodium thiosulphate, Potassium permanganate

Complexometric titration Ex: Calcium chloride (Cacl2), Magnesium (Mg) and Metals

Non-aqueous titration for Drug intermediates and APIs Ex: 2-Amino Pyridine, Isonipotic acid etc..

Gravimetric analysis:

Gravimetric analysis is the mass of an ion in a compound and is determined to find out the mass per cent of the same ion in a known quantity of a compound.

Examples 1) The amount of sulphate as barium sulphate(BaSO4) from sodium sulphate(NaSO4).

2) Content of Nickel in Raney-Nickle catalyst and Palladium in Pd/C catalyst.

Wet laboratory, some important chemical analyses are

Ex: Water content(WC), Loss on drying(LOD), Residue on ignition(ROI), Specific Optical Rotation(SOR), Wt per mL, Thin Layer Chromatography(TLC), Tapped density, Friebilty, Dissolution, Disintegration etc.

Water Analysis:

Softener water: This water is used for boiler purposes to generate steam.

Demineralized or Deionised water: This water is used for chemical analysis and process areas.

Purified water: This water is used for the manufacturing process.

Three samples are collected to be analysed to their specification (WHO) and Standard testing procedures as per scheduled.

Instrumental methods of Chemical analysis

1) Chromatography: 

Instrumental analysis to analyse quantitative and qualitative investigates analytes using the help of scientific instruments.

There are main two instrumental analyses carried out for Quality Control in the Pharmaceutical industry.

This technique separates and identifies the mixture of the compounds based on their relative affinity amounts of each compound distributed between a moving mobile phase, and a stationary phase. Mostly used instruments of Quality Control in the Pharmaceutical industry

          1) High-Performance Liquid Chromatography (HPLC)           2) Gas Chromatography (GC)

2) Spectrophotometry:

Spectroscopic techniques are to pass a beam of electromagnetic radiation onto an unknown sample and observe to find out the difference between energy levels with reference.

Most commonly used spectrophotometers of Quality Control in the Pharmaceutical industry. There are 

           1) Ultra-Violet Spectrophotometer (UVS)            2) Fourier-transform infrared spectrometer (FTIR) and NIR  3) Atomic Absorption Spectrometer (AAS) and FAS

These are the main used Research Centres for Structure elucidations and Analytical Method Development.

          1) Nuclear Magnetic Resonance Spectrometer (NMR)

          2) Mass Spectrometer (MS)

3) Thermo Gravimetric Analysis (TGA)

4) Differential Thermal Analysis (DTA)

Stability Studies:

Stability studies are conducted for a re-test or expiry or a shelf life period for the drug substance or the drug product and recommended storage conditions.

These are analysed as per protocol or stability STP based on the schedule.

           1) Hold-time stability studies            2) Long-term, Accelerated, intermediate condition studies

The quality control department follows systematic proper online documentation, Logbooks, Registers, Good Laboratory Practices (GLP) and Good Documentation Practices.

After complete analysis, documented respective analysis signed and checked authorised persons to prepare the certificate of analysis approved by the Head of the department or Designee.

Backup Electronic Data:

All electronic data stored in their servers or external hard disks are Empower network or Lab solution or Open Lab software and its data is backed up and retrieved every week by an IT person.

 Conclusion:

The Quality Control department checks each step of the product manufacturing as per specification and standard testing procedures after releasing documented data.

[synnatpharma11]

Sertraline Mandelate Intermediates Manufacturer

Sertraline Mandelate Intermediates Manufacturer

Sertraline Mandelate is utilized for treating depression, depressive disorders, obsessive-compulsive disorder, panic disorder, and similar conditions. It enhances mood, thereby reducing the impact of these conditions and helping restore normal functioning by rebalancing serotonin levels in the brain.

India serves as a hub for numerous manufacturers of sertraline mandelate intermediates, as well as a wide range of APIs and intermediates for various medical applications. These companies specialize in the bulk production and distribution of high-quality pharmaceuticals for both domestic and international clients, adhering to stringent quality standards.

While securing a reliable sertraline mandelate intermediates supplier may be relatively straightforward due to the number of companies in the field, finding a long-term partner that can adapt to your evolving business needs can be more challenging.

We would like to introduce Synnat Pharma, an internationally recognized company specializing in APIs and intermediates with a presence in over 30 countries. Despite being in the industry for just over a decade, we have gained the trust and confidence of our clients by staying true to our vision: providing effective medical solutions at compelling prices. We comply with multiple quality standards, including WHO, EDQM, CDSCO, and PMDA, reflecting our commitment to excellence.

Choose Synnat Pharma not only because we are among the leading manufacturers of sertraline mandelate intermediates, but also because we are dedicated to advancing healthcare by delivering innovative medical solutions that shape the future of the industry.

[sudheervanguri]

Amoli Organics Walk-In Drive for Production and Quality Control Amoli Organics, a division of Umedica Laboratories Pvt. Ltd., is hosting a walk-in drive for various positions in Production and Quality Control at its Vapi Plant. This is a prime opportunity for individuals with qualifications in BSc Chemistry, MSc Chemistry, or ITI to advance their careers with a company known for its expertise in Active Pharmaceutical Ingredients (APIs) manufacturing. About Amoli Organics Established in 1992, Amoli Organics has grown to become a leading manufacturer of APIs, collaborating with global healthcare leaders. With state-of-the-art facilities in Mumbai, India, the company meets the stringent standards of the global pharmaceutical industry, having received approvals from EDQM and USFDA. Amoli Organics is dedicated to innovation, quality, and expanding its global footprint in the healthcare sector. Available Positions in Production and Quality Control 1. Production Department Officer / Sr. Officer Qualification: MSc Chemistry, B.E, B Tech Chemical, BSc Chemistry Experience: 0-5 years Skills Required: Knowledge of API Plant operations, equipment handling, GMP compliance, and good documentation practices. Tr. Associate / Associate Qualification: BSc Chemistry, ITI AOCP Experience: 1-3 years Skills Required: Experience in API Plant operations, equipment handling, GMP knowledge, and good documentation practices. Apprentice Qualification: BSc Chemistry, ITI AOCP Experience: Fresher Vacancies: 20 Responsibilities: Gain hands-on experience in API Plant operations, learn equipment handling, and understand GMP documentation. [caption id="attachment_100528" align="aligncenter" width="930"] Amoli Organics Announces Walk-In Drive for Production and Quality Control[/caption] 2. Quality Control Department Officer / Executive / Sr. Executive Qualification: MSc Analytical/Organic Chemistry Experience: 2-7 years Skills Required: Proficiency in HPLC, GC, Autotitrator, UV, FITR, Chromeleon 7.2, Lab Solution, and Tiamo software. Jr. Associate / Associate Qualification: BSc Chemistry, ITI LACP Experience: 0-2 years Skills Required: Knowledge of sampling of raw materials, API, and intermediates. Walk-In Drive Details Interview Dates: 6th September 2024 & 8th September 2024 Time: 10:00 A.M. to 3:00 P.M. Venue: Amoli Organics, Plot No. 322/4, 40 Shed Area, GIDC, Vapi-396195

[ihspl]

Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

[pharmawalksjobs]

Ind-Swift Ltd walk-in interview for Packing, QC on 13th July 2024

Ind-Swift Laboratories Ltd., based in Chandigarh, India, has positioned itself as a leading worldwide producer of APIs, Intermediates, and formulations through collaborative endeavors. With operations at more than 6 regulated manufacturing facilities, including 2 group subsidiaries in Punjab and Jammu, we are committed to fulfilling the API needs of regulated markets like USFDA, EDQM, PMDA,…

[formiforma]

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[wealthview]

SPC Life Sciences IPO Date, Price, Review, Company Profile, Risk, Financials 2023

New Post has been published on https://wealthview.co.in/spc-life-sciences-ipo/

SPC Life Sciences IPO Date, Price, Review, Company Profile, Risk, Financials 2023

SPC Life Sciences IPO: SPC Life Sciences Ltd. is a leading manufacturer of advanced intermediates used in critical active pharmaceutical ingredients (APIs) for therapeutic areas like cardiovascular, vasodilator, anti-psychotic, and anti-depressants. They cater to both domestic and international markets, serving renowned pharmaceutical companies.

SPC Life Sciences IPO Details:

Dates: SPC Life Sciences IPO hasn’t officially launched yet.

Offer Size: The planned offer size is around ₹300 crores (~US$36 million), comprising a fresh issue of ₹300 crores and an offer for sale (OFS) of up to 89.39 lakh equity shares.

Price Band: The price band hasn’t been announced yet.

Recent News Updates:

SEBI Approval: SPC Life Sciences received approval from the Securities and Exchange Board of India (SEBI) in March 2023 to launch the IPO. However, there haven’t been any significant updates since then.

Market Conditions: The current market scenario might impact investor sentiment towards the IPO. The global economic slowdown and ongoing geopolitical tensions have led to volatility in the stock market, which could dampen investor enthusiasm for new issuances.

Industry Growth: Despite market fluctuations, the pharmaceutical intermediates market is projected to grow steadily in the coming years, driven by factors like rising demand for generic drugs and increasing R&D in complex APIs. This could be a positive signal for SPC Life Sciences’ long-term potential.

SPC Life Sciences Company Profile:

Founded in 2006 in Vadodara, Gujarat, SPC Life Sciences has emerged as a leading manufacturer of advanced intermediates for critical Active Pharmaceutical Ingredients (APIs). Their journey can be summarized in key milestones:

2006: Established with a focus on basic and advanced intermediates for cardiovascular and vasodilator drugs.

2010: Expanded operations to include anti-psychotic and anti-depressant APIs.

2014: Achieved USFDA and EDQM certifications, opening doors to international markets.

2018: Set up a dedicated R&D facility, focusing on developing custom APIs and complex molecules.

2023: Received SEBI approval for the proposed IPO, aiming to raise capital for further expansion.

Operations and Market Position:

SPC Life Sciences operates across three state-of-the-art manufacturing facilities in India, catering to both domestic and international pharmaceutical companies. They boast a diverse product portfolio of over 150 advanced intermediates, with a strong presence in therapeutic areas like:

Cardiovascular

Vasodilator

Anti-psychotic

Anti-depressant

Anti-diabetic

Their market share in specific niche segments within these areas is noteworthy, particularly for certain complex intermediates. However, the overall market share for the entire Indian API and intermediates industry is fragmented, with a large number of players.

Key Facts:

Founded: 2006

Headquarters: Vadodara, Gujarat, India

Facilities: 3 state-of-the-art manufacturing units

Products: 150+ advanced intermediates

Therapeutic Areas: Cardiovascular, vasodilator, anti-psychotic, anti-depressant, anti-diabetic

Certifications: USFDA, EDQM

Prominent Brands, Subsidiaries, and Partnerships:

While SPC Life Sciences primarily operates under its own brand name, they also manufacture intermediates for several renowned pharmaceutical companies. They maintain strategic partnerships with leading players in the industry but currently don’t have any major subsidiaries.

Competitive Advantages and Unique Selling Proposition:

SPC Life Sciences’ competitive edge lies in:

Strong focus on niche, high-value advanced intermediates: This caters to the growing demand for complex APIs used in innovative drugs.

Commitment to quality and regulatory compliance: USFDA and EDQM certifications ensure adherence to international standards.

Experienced team and robust R&D capabilities: Their expertise in process development and optimization allows them to tailor solutions for specific customer needs.

Cost-effective production: Utilizing advanced technology and efficient processes, they offer competitive pricing.

Unique Selling Proposition: SPC Life Sciences positions itself as a reliable and innovative partner for pharmaceutical companies seeking high-quality, cost-effective advanced intermediates for complex APIs. Their focus on niche segments and commitment to R&D differentiates them in the competitive API and intermediates market.

Analyzing SPC Life Sciences’ financials in detail is currently not possible due to the lack of finalized IPO documents and audited financial statements beyond FY22. However, based on available information and preliminary reports, here’s an overview of their financial performance and future prospects:

Recent Financial Performance:

Revenue Growth: SPC Life Sciences has demonstrated consistent revenue growth, with FY22 seeing a 7% increase to Rs. 146 crore compared to Rs. 136 crore in FY21. This upward trend is expected to continue in FY23, with reports suggesting sales reaching Rs. 132.72 crore in 9MFY23.

Profitability: The company has also exhibited healthy profitability, with a 16% increase in profit before tax (PBILDT) to Rs. 25 crore in FY22 and an 18% rise in net profit to Rs. 19 crore. Their PAT margin stood at 32.59% in FY22.

Debt Levels: While the exact debt details haven’t been officially disclosed, reports suggest modest debt levels with an overall gearing ratio of 0.79 times as on March 31, 2022. The company intends to use a portion of the IPO proceeds for debt reduction, further improving its financial health.

Future Growth Prospects and Earnings Drivers:

SPC Life Sciences possesses promising potential for future growth driven by several factors:

Rising Demand for APIs and Intermediates: The global API and intermediates market is projected to grow steadily, fueled by increasing R&D in complex APIs and generic drug demand.

Strong Product Portfolio and Niche Focus: Their diverse product portfolio catering to niche, high-value advanced intermediates positions them well in this growing market segment.

Expansion Plans: The planned IPO funds will enable them to expand their manufacturing capacity, introduce new products, and strengthen R&D capabilities, boosting future growth.

Focus on Quality and Regulatory Compliance: Adherence to stringent international standards like USFDA and EDQM opens doors to global markets and attracts major pharmaceutical clients.

SPC Life Sciences IPO objectives:

Reasons for Going Public:

SPC Life Sciences plans to raise around Rs. 300 crore through its proposed IPO with two primary objectives:

Funding Expansion Plans: The company intends to utilize a major portion of the raised funds for expanding its manufacturing capacity. This includes setting up Phase-II of their Dahej facility, enabling them to introduce new product offerings and cater to the growing demand for their advanced intermediates.

Debt Reduction and Working Capital Improvement: They plan to allocate a portion of the IPO proceeds towards repaying existing debt and strengthening their working capital. This will improve their financial health and provide flexibility for future operations.

Alignment with Growth Strategy:

These objectives align well with SPC Life Sciences’ stated future growth strategy, which focuses on:

Strengthening their position in niche segments: Expanding their manufacturing capacity allows them to cater to the increasing demand for their existing high-value advanced intermediates and potentially venture into new niche segments within the API and intermediates market.

Investing in R&D: They plan to utilize a portion of the funds for R&D activities, allowing them to develop new innovative intermediates and optimize production processes, furthering their technological edge.

Improving operational efficiency: Reducing debt and bolstering working capital will enhance their financial stability and operational efficiency, making them more competitive in the market.

SPC Life Sciences IPO Risks:

Investing in any IPO involves inherent risks, and SPC Life Sciences is no exception. Before making any investment decisions, it’s crucial to consider the following potential risks and concerns.

Industry Headwinds:

The API and intermediates market is subject to various external factors beyond the company’s control, such as:

Regulatory changes: Stringent regulations and quality standards can significantly impact production costs and timelines.

Raw material availability and pricing: Fluctuations in the availability and cost of raw materials can affect profitability.

Competition: The Indian API and intermediates market is fragmented, with numerous players competing for market share. This can pressure pricing and margins.

Company-Specific Challenges:

While SPC Life Sciences boasts a strong track record, some concerns need consideration:

Limited track record as a publicly traded company: As a new entrant to the public market, there’s limited historical data for investors to analyze.

Reliance on few customers: The company derives a significant portion of its revenue from a few major customers. If any of these clients discontinue their business with SPC Life Sciences, it could negatively impact their finances.

Debt repayment: Although they plan to utilize a portion of the IPO proceeds for debt reduction, their current debt-to-equity ratio might still be a concern for some investors.

Also Read: How to Apply for an IPO?

[bridgemedsolutions]

[aartipharmalabs]

Serving our global clients with our full spectrum of services for their API and Drug Substance Manufacturing needs

Aarti Pharmalabs specializes in the clinical phase and commercial production of APIs and NCEs, Intermediates, Regulatory Starting Materials, Key Building Blocks and Xanthine Derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production.

Our operations include 2 R&D centers and 6 manufacturing facilities and our 3 cGMP pharmaceutical products manufacturing plants have been successfully audited by USFDA, EUGMP, EDQM, KFDA and COFEPRIS etc.

[serresvoice]

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Ανάκληση φαρμάκων από τον ΕΟΦ – «Συναγερμός» για καρκινογόνα ουσία

Στην ανάκληση φαρμάκων προχώρησε ο ΕΟΦ, μετά και τις ενέργειες του ευρωπαϊκού οργανισμού EDQM που απέσυρε το πιστοποιητικό καταλληλότητας για τη δραστική ουσία βαλσαρτάνη, που παράγεται από το εργοστάσιο Zheijiang Tianyu Pharmaceutical Co Ltd (Κίνα).

Η επανεξέταση από τον Ευρωπαϊκό Οργανισμό Φαρμάκων της βαλσαρτάνης σε σχέση με το NDMA συνεχίζεται και ο Οργανισμός συνεργάζεται στενά με την…

[sudheervanguri]

Titan Laboratories Hiring for Regulatory Affairs API in Navi Mumbai Join Titan Laboratories Pvt Ltd as a Regulatory Affairs API Professional Titan Laboratories Pvt Ltd, a leader in pharmaceutical manufacturing, is seeking experienced professionals for the position of Regulatory Affairs API at their Navi Mumbai (Turbhe) Head Office. If you have 9+ years of experience in regulatory submissions and lifecycle management, this is an excellent opportunity to advance your career. Job Responsibilities As an Officer/Sr. Officer/Executive/Sr. Executive/Asst. Manager in Regulatory Affairs API, you will be responsible for: Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO and ROW market. Preparing Nitrosamine Risk Assessment Report for Sartans and other drug substances. Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to the respective regulatory authorities through electronic submissions. (ESG, CESP submissions) Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on changes proposed for the drug Substances. Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.  Preparing and compiling DMF/Technical Packages & Dossiers for submission to the Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW). Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC Documentation. Compiling eCTD sequences through Pharmaready. Review of Validation reports, Stability studies, Specifications/ Method of Analysis, Batch Manufacturing Records (BMR’s/MFR’s), Pharmaceutical Development Reports (PDR). Interact with various departments/teams for regulatory documents and compilation on time as per regulatory requirements. Maintenance of the complete history of each drug substance (Filing history with agencies/customers, deficiency responses, amendments, annual reports)  Issue Letter of Access and other relevant regulatory documents and their submission to regulatory authorities.  Review of all documents from QA, R&D, AR&D, Production and other department with respect to correctness and compliance for regulatory submission. Audit Faced: WHO-GENEVA, USFDA, EDQM and Customer audits. Qualifications Experience: 9+ years in Regulatory Affairs API. Educational Background: M. Pharma or B. Pharma. Location: Navi Mumbai (Turbhe) Head Office. How to Apply Interested candidates can share their resumes with Shweta M at shweta.m@titanpharma.com. [caption id="attachment_79912" align="aligncenter" width="930"] Titan Laboratories Pvt Ltd Recruitment - Job vacancies[/caption]

[luigiderosa]

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.

The report presents the results of the multinational validation study aimed at validating 4 basic sets of indicators to assess the quality of pharmaceutical care in Europe. It also contains the data collection forms that were developed and used in the above validation study. This report will…

[pharmawalksjobs]

Ind-Swift walk-in interview for Production, Packing, QC, Engineering on 22nd June 2024

Ind-Swift Laboratories Ltd., based in Chandigarh, India, has positioned itself as a leading worldwide producer of APIs, Intermediates, and formulations through collaborative endeavors. With operations at more than 6 regulated manufacturing facilities, including 2 group subsidiaries in Punjab and Jammu, we are committed to fulfilling the API needs of regulated markets like USFDA, EDQM, PMDA,…

[eldoqmentalistaoficial]

Yo Soy, #EDQM, Y Esto Es: ANIMALES CON PODERES MISTERIOSOS