BIS Certification for Gamma Picoline | IS 16113:2013 – Qualitance India

BIS Certification for Gamma Picoline – IS 16113:2013

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BIS Certification for Gamma Picoline – IS 16113:2013

Gamma Picoline is a chemical compound used as an industrial chemical intermediate in various chemical manufacturing applications. To ensure product quality and conformity with Indian requirements, the Government of India has brought Gamma Picoline under the compulsory BIS certification framework through the Gamma Picoline (Quality Control) Order, 2020.

Manufacturers supplying Gamma Picoline in the Indian market must comply with the applicable Indian Standard, IS 16113:2013 – Gamma Picoline: Specification, and obtain the BIS licence before applying the Standard Mark to their product.

The certification process involves product testing, factory assessment, quality-control arrangements, documentation and compliance with the applicable BIS Scheme-I requirements.

1. Is BIS Certification Mandatory for Gamma Picoline?

Yes. BIS certification is mandatory for Gamma Picoline covered under IS 16113:2013.

The Department of Chemicals and Petrochemicals lists Gamma Picoline under the Gamma Picoline (Quality Control) Order, 2020, notified through S.O. 1891(E), dated 16 June 2020.

The original implementation date was subsequently amended. The Department’s QCO listing records the final implementation date as 13 March 2023, following the amendments to the Order.

Under the QCO, Gamma Picoline must conform to IS 16113:2013 and bear the BIS Standard Mark under a licence issued by BIS in accordance with Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.

The QCO does not apply to goods or articles meant for export, as provided in the Order.

Regulatory reference: Department of Chemicals and Petrochemicals – Chemicals Quality Control Orders.

2. Applicable Indian Standard – IS 16113:2013

The applicable product standard is:

Particular	Details
Product	Gamma Picoline
Indian Standard	IS 16113:2013
Standard title	Gamma Picoline – Specification
Certification scheme	BIS Scheme-I (ISI Mark Scheme)
Certification authority	Bureau of Indian Standards (BIS)
QCO	Gamma Picoline (Quality Control) Order, 2020
Certification status	Mandatory

BIS has published a product manual for Gamma Picoline, reference PM/16113/2, April 2024, which provides guidance on sample quantity, testing equipment, inspection and testing arrangements, laboratory requirements and marking.

The product manual records one amendment to IS 16113:2013. Applicants should check the latest applicable standard and amendments before preparing their testing and certification documentation.

3. Key Quality Requirements for Gamma Picoline

As per IS 16113:2013, Gamma Picoline is evaluated against the product requirements specified in the standard.

The BIS product manual identifies the following principal characteristics for assessment:

1. Description of the product
2. Solubility
3. Gamma Picoline content
4. 2-Ethyl Pyridine content
5. Alpha Picoline content
6. Beta Picoline content
7. 2,6-Lutidine content
8. Other unknown impurities
9. Moisture content

These parameters are important for verifying the composition and quality of Gamma Picoline.

The precise acceptance limits and test methods must be taken from the applicable edition of IS 16113:2013 and its amendments. Manufacturers should not rely on generic chemical specifications or internal product specifications as a substitute for the Indian Standard.

4. Testing Requirements for BIS Certification

Testing is a critical part of the BIS certification process. The manufacturer must demonstrate that the product meets the requirements of IS 16113:2013.

The BIS product manual identifies the following tests:

Test parameter	Test method / reference
Description	Clause 3.1
Solubility	Clause 3.2
Gamma Picoline content	Clause 3.3, Table 1
2-Ethyl Pyridine content	Clause 3.3, Table 1
Alpha Picoline content	Clause 3.3, Table 1
Beta Picoline content	Clause 3.3, Table 1
2,6-Lutidine content	Clause 3.3, Table 1
Other unknown impurities	Clause 3.3, Table 1
Moisture content	Clause 3.3, Table 1

Gas Chromatography Testing

Gas chromatography is used for determining Gamma Picoline content and the specified related components and impurities.

The BIS product manual identifies a Gas Chromatograph equipped with a Flame Ionization Detector (FID), data acquisition system and suitable chromatographic column as the relevant testing equipment.

The manual provides indicative chromatographic conditions, including a CP-Sil-52CB Wax column. However, alternative GC configurations and calibration techniques may also be used, provided the required resolution, standardisation and calibration are established.

Moisture Content Testing

Moisture content is determined using the Karl Fischer method.

The equipment and materials identified in the BIS product manual include:

• Karl Fischer titrator with electrometric endpoint detection
• Pyridine-free Karl Fischer reagent
• Analytical balance
• Hot air oven
• Distilled water
• Required chemical reagents and glassware

The manufacturer must ensure that the testing methods and equipment are suitable for the relevant requirements of the Indian Standard.

5. Sample Quantity Required for BIS Testing

As per the BIS Product Manual PM/16113/2, April 2024:

Sample quantity: 200 grams

The product manual does not specify a separate grouping guideline for Gamma Picoline. It records the grouping requirement as Not Applicable.

The sample quantity is the quantity indicated for laboratory testing during grant of licence, change in scope of licence and factory surveillance, subject to the applicable BIS requirements.

Manufacturers should coordinate sample identification, sealing and dispatch with the concerned BIS office or laboratory before sending the sample.

6. Factory Laboratory and Testing Facilities

The manufacturer must establish appropriate quality-control and testing arrangements to ensure that Gamma Picoline consistently conforms to IS 16113:2013.

The BIS product manual provides different provisions depending on the scale of the manufacturing unit.

Large-Scale Manufacturers

Large-scale manufacturers are expected to maintain an adequately equipped in-house laboratory for routine tests identified in the Scheme of Inspection and Testing.

They must also:

• Maintain suitable testing equipment.
• Implement a calibration plan.
• Maintain test records.
• Establish routine quality-control procedures.
• Ensure that the product conforms to all applicable requirements of IS 16113:2013.

MSME Manufacturers

For MSME manufacturers, maintaining an in-house laboratory for routine tests is optional under the provisions of the product manual.

MSME units may use:

• Common cluster-based testing facilities.
• Shared testing facilities.
• BIS-recognised or empanelled laboratories.
• Laboratories having valid NABL accreditation as per IS/ISO/IEC 17025.

Subcontracted Testing

Testing may be subcontracted to a BIS-recognised or empanelled laboratory or another laboratory having valid NABL accreditation as per IS/ISO/IEC 17025, subject to the product manual’s provisions.

The manufacturer must retain the relevant laboratory test reports for inspection by BIS.

7. Scheme of Inspection and Testing (SIT)

The manufacturer is required to implement a Quality Assurance Plan covering inspection, testing and in-process quality control.

The BIS product manual recommends that the entire quantity of product manufactured in a single batch be treated as one control unit.

The recommended levels of control include:

Parameter	Recommended sample frequency
Description	Adequate in-process controls and records
Solubility	Adequate in-process controls and records
Gamma Picoline content	One sample from each control unit
2-Ethyl Pyridine content	One sample from each control unit
Alpha Picoline content	One sample from each control unit
Beta Picoline content	One sample from each control unit
2,6-Lutidine content	One sample from each control unit
Other unknown impurities	One sample from each control unit
Moisture content	One sample from each control unit

The manufacturer must prepare and submit a Quality Assurance Plan to the concerned BIS Branch Office for information.

The plan should define the control unit, frequency of testing, number of samples and relevant quality-control activities.

The manufacturer must maintain records demonstrating conformity of the entire production covered under the plan.

8. Packing and Marking Requirements

Gamma Picoline supplied under a BIS licence must comply with the packing and marking requirements of IS 16113:2013 and the applicable BIS licence conditions.

The BIS Standard Mark must be incorporated legibly and indelibly on the container transporting Gamma Picoline, provided that the material conforms to all applicable requirements of the standard.

Marking on Tankers and Bulk Containers

Where Gamma Picoline is supplied through tank cars, tank trucks or container ships, the Standard Mark and BIS licence number (CM/L number) must be included on the test certificate accompanying the consignment.

The BIS product manual also specifies the following additional marking requirement on the container:

“For BIS certification details please visit www.bis.gov.in”

Manufacturers must ensure that the product is marked only after conformity with the applicable requirements has been established.

9. Documents Required for BIS Certification of Gamma Picoline

Applicants should prepare the following documents for the BIS certification process.

A. Company and Legal Documents

• Company incorporation certificate or registration proof
• GST registration certificate
• PAN card of the company or proprietor
• Factory address proof
• Authorised signatory details
• Authorisation letter or board resolution, wherever applicable
• Details of manufacturing premises

B. Manufacturing Documents

• Manufacturing process flow chart
• Detailed manufacturing process description
• List of raw materials and their specifications
• List of manufacturing machinery and equipment
• Plant layout
• Production capacity details
• Details of storage and handling facilities
• Product identification and batch numbering procedure

C. Quality Control Documents

• Quality Control Manual
• Quality Assurance Plan
• Scheme of Inspection and Testing
• In-house laboratory details
• List of testing equipment
• Equipment calibration certificates
• Test formats and records
• Internal quality-control procedures
• Product test reports, where available

D. BIS Application Documents

• BIS application and supporting declarations
• Details of the product proposed for certification
• Factory and manufacturing details
• Undertakings and declarations required by BIS
• Applicable application and processing fee payment details

The exact document requirement may vary depending on the applicant’s manufacturing setup, company structure and applicable BIS application procedure.

10. Step-by-Step BIS Certification Process for Gamma Picoline

The general process for obtaining a BIS licence under Scheme-I is as follows:

Step 1 – Applicability and Standard Review

Confirm that the product falls within the scope of IS 16113:2013 and the Gamma Picoline Quality Control Order.

Step 2 – Factory and Infrastructure Assessment

Review the manufacturing process, plant facilities, testing arrangements, quality-control system and product handling facilities.

Step 3 – Documentation Preparation

Prepare the required company, manufacturing, quality-control and technical documents.

Step 4 – BIS Application Submission

Submit the application through the applicable BIS certification process along with the prescribed documents and fees.

Step 5 – Factory Inspection

BIS evaluates the manufacturing premises, production process, quality-control arrangements, testing facilities and implementation of the relevant requirements.

Step 6 – Sample Drawal and Testing

Samples are drawn and tested as per IS 16113:2013. The product manual specifies a sample quantity of 200 grams.

Step 7 – Compliance and Clarifications

The applicant addresses any observations, non-conformities or additional requirements raised during the certification process.

Step 8 – Grant of BIS Licence

After satisfactory assessment and fulfilment of applicable requirements, BIS may grant the licence to use the Standard Mark for Gamma Picoline.

11. BIS Testing Charges for Gamma Picoline

The BIS Laboratory Information Management System (LIMS) displays a testing charge breakup for IS 16113:2013 at the laboratory listing reviewed.

The displayed charges are:

Testing parameter	Listed charge (excluding taxes)
Solubility	₹800
Gamma Picoline content	₹2,500
2-Ethyl Pyridine content	₹2,500
Alpha Picoline content	₹2,500
Beta Picoline content	₹2,500
2,6-Lutidine content	₹2,500
Other unknown impurities	₹2,500

The displayed breakup totals ₹15,800 for these listed parameters. The LIMS page shows a total testing charge of ₹16,800, so applicants should obtain a current laboratory quotation and confirm the complete test scope before making payment.

These are laboratory-listed testing charges, not the complete cost of obtaining a BIS licence. Taxes, application fees, inspection charges, marking fees and other applicable costs must be considered separately.

12. How Long Does BIS Certification Take?

The time required for BIS certification depends on several factors, including:

• Completeness of the application and supporting documents
• Readiness of the manufacturing premises
• Availability of testing facilities
• Factory inspection scheduling
• Sample testing and laboratory turnaround time
• Closure of observations or non-conformities
• Completion of BIS formalities

There is no fixed completion period that can be guaranteed for every applicant. A realistic project timeline should be assessed after reviewing the factory’s readiness and the applicable testing arrangements.

13. Common Challenges in Obtaining BIS Certification

Manufacturers may face the following challenges during the certification process:

1. Inadequate laboratory facilities: Required testing equipment and calibration arrangements may not be available.
2. Improper quality-control documentation: The Quality Assurance Plan and Scheme of Inspection and Testing may not be properly prepared.
3. Testing failures: The product may not meet one or more chemical composition or impurity requirements.
4. Incomplete manufacturing records: Batch-wise production and test records may be insufficient.
5. Incorrect marking: The Standard Mark, licence number or accompanying test certificate may not comply with BIS requirements.
6. Unclear control-unit definition: The manufacturer may not have established a suitable batch-wise inspection and testing system.

Proper preparation before submitting the BIS application can help reduce avoidable delays.

14. How Qualitance India Can Help

Qualitance India provides professional BIS certification and regulatory compliance consultancy services to manufacturers and businesses seeking BIS licences in India.

For Gamma Picoline certification under IS 16113:2013, our support can include:

• BIS certification applicability assessment
• Review of IS 16113:2013 requirements
• Factory infrastructure and laboratory gap assessment
• Preparation of BIS application documentation
• Preparation of Quality Assurance Plan and Scheme of Inspection and Testing
• Guidance on testing equipment and laboratory arrangements
• Coordination support for product sample testing
• Assistance during BIS factory inspection
• Support in responding to BIS observations
• Guidance through the BIS licence grant process

Our objective is to help manufacturers establish a compliant certification system and complete the BIS certification process efficiently.

Qualitance India – Improving Quality & Competence

Website: https://qualitanceindia.com
Email: info@qualitanceindia.com
Contact: +91 93106 15170

15. Frequently Asked Questions (FAQs)

Q1. Is BIS certification mandatory for Gamma Picoline in India?

Yes. Gamma Picoline is covered under the Gamma Picoline (Quality Control) Order, 2020. Manufacturers supplying the product in the Indian market must comply with IS 16113:2013 and obtain the applicable BIS licence, subject to the exclusions specified in the Order.

Q2. Which Indian Standard applies to Gamma Picoline?

The applicable Indian Standard is IS 16113:2013 – Gamma Picoline: Specification.

Q3. Under which BIS scheme is Gamma Picoline certified?

Gamma Picoline is certified under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.

Q4. What is the sample quantity required for Gamma Picoline testing?

The BIS Product Manual PM/16113/2, April 2024, specifies a sample quantity of 200 grams.

Q5. What are the major tests required for Gamma Picoline?

The major parameters include solubility, Gamma Picoline content, 2-Ethyl Pyridine, Alpha Picoline, Beta Picoline, 2,6-Lutidine, other unknown impurities and moisture content.

Q6. Is an in-house laboratory mandatory?

For large-scale manufacturers, the product manual expects an in-house laboratory for routine testing, or use of applicable shared testing facility provisions. For MSME manufacturers, the in-house laboratory requirement for routine tests is optional under the stated provisions.

Q7. Can testing be outsourced?

Yes. Subcontracting is permitted to BIS-recognised or empanelled laboratories or laboratories having valid NABL accreditation as per IS/ISO/IEC 17025, subject to the applicable provisions of the product manual.

Q8. Can imported Gamma Picoline be sold in India without BIS certification?

The QCO applies to covered goods supplied in India, subject to its stated exclusions. Importers should ensure that the applicable BIS licensing and marking requirements are fulfilled before placing covered Gamma Picoline on the Indian market. Goods meant for export are excluded under the Order.

Q9. What is the BIS testing cost for Gamma Picoline?

The BIS LIMS listing reviewed displays a total testing charge of ₹16,800 excluding taxes for IS 16113:2013. The actual amount should be confirmed with the selected laboratory before sample submission.

Q10. Who can assist with BIS certification for Gamma Picoline?

Qualitance India can assist manufacturers with BIS applicability assessment, documentation, laboratory and testing arrangements, factory inspection preparation and certification coordination.

Conclusion

BIS certification for Gamma Picoline is a mandatory compliance requirement under the Gamma Picoline (Quality Control) Order, 2020. Manufacturers must ensure that their product conforms to IS 16113:2013 and that their manufacturing and quality-control systems meet the applicable BIS certification requirements.

A structured approach to documentation, testing, laboratory readiness and factory inspection can help manufacturers manage the certification process effectively.

For professional assistance with BIS Certification for Gamma Picoline, contact Qualitance India.

Qualitance India – Improving Quality & Competence

Website: https://qualitanceindia.com
Email: info@qualitanceindia.com
Phone: +91 93106 15170

 

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