Natural Capsules Limited strictly adheres to the Quality Assurance procedures mandated by cGMP.
At Natural Capsules Limited, Quality Assurance plays an integral part in monitoring all critical process parameters like, temperature and humidity, measurable parameters like, weight, length, outside diameter, dome thickness, wall thickness, profile, physico-chemical & bacteriological tests and well defined systematic approach that eliminates error in every stage of production to explore a product to meet the customer requirement / satisfaction.
Every activity is closely monitored by IPQC Inspectors, to evaluate the quality and hence attaining the desired Product Quality.NCL follow various systems in accordance with ISO 9001:2000 to assure that each activity is carried out in a defined way as per the system.
The Quality Control measure starts with the usage of the best indigenous pharmaceutical grade Gelatin – the main raw material required for the manufacturing, atomized capsule manufacturing machines, a sophisticated quality control laboratory, a well documented system has put Natural Capsules to produce consistently Zero Defect Product meeting to Customer requirement.
A regular and planned training program addressing the training needs enable Natural Capsules to maintain the QMS from Top Management to Bottom Line, which has provided a consistency in the Systemic approach.
Capsules manufactured by Natural Capsules meets the requirement of Regulatory Authorities. Besides meeting the requirement, In-house specifications are laid down to meet the customer changing requirements for efficient Quality and Machinability. The following are the few specifications :
|Length (mm)||OutSide Diameter (mm)|
|Size||Caps||Body||Weight (mg)||Close Joined Length (mm)||Cap||Body|
|Powder density g/ml||Powder weight in mg.|
Hard Gelatin Capsule Shells
Hard Cellulose Capsule Shells
Flow diagram of pre - production and post - production process of Capsule Dosage Form : (Click here)
• ISO 9001:2000 certified Company
• WHO – GMP certified Facility
1. Hard Cellulose Capsules – 18357, dated 10/06/2005
2. Hard Gelatin Capsules – 18358, dated 10/06/2005
• Halal Registered Company – Registration No. 200, dated 5/9/2005
Regulatory Information on Capsule Product
• Natural Capsules manufactures Gelatin Capsules from Gelatin that complies with the requirements of:
1. The Indian Pharmacopoeia (IP) : 1996
2. The United States Pharmacopoeia (USP) : XXIV
3. National Formulary (NF) 19
• Natural Capsules provides confidential information about facilities, processes, materials used in manufacturing, processing, packaging and storing of empty capsules through Type IV (Excipient) Drug Master File submitted to the USFDA.
• Natural Capsules manufactures Gelatin capsules from Gelatin that complies with requirements related to Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE).
• Natural Capsules – VG-Caps capsules of plant origin are approved by the Vegetarian Society and the process is Halal Certified.
Regulatory Information on Capsule Manufacturing Process & ISO Compliance
• At Natural Capsules, Capsules are manufactured under controlled climate conditions (Class 100,000) in accordance with Revised Schedule ‘M’, using a dipping process on automatic capsules manufacturing machines.
• A thorough inspection and continuous monitoring of critical process and measurable parameters provides Zero Defect product
• Imprinting of the capsules, if desired by the customer, is undertaken before the capsules are transferred to final packing
Regulatory Information on Colorants
• The colorants used by Natural Capsules in the manufacturing process of capsules comply with requirements of:
The Bureau of Indian Standards (BIS)
• Titanium Dioxide (Opacifying Agent) used in the manufacturing process of capsules comply with requirements of:
The Indian Pharmacopoeia (IP)
The United States Pharmacopoeia (USP)
• Printing Inks used for capsule printing and monogramming comply with requirements of:
• The Bureau of Indian Standards (BIS)
Regulatory Information on Packaging and Shipment
• Handling – As capsules are very susceptible to outside temperature and humidity, they should be kept away from heat sources and other environmental extremes to keep capsules from being heat damaged, deformed and sticky.
• The following conditions should be kept to maintain shelf-life of capsules:
1. Ideal Storage Conditions : The packed corrugated boxes should be stored on pallets in a well protected area at a temperature between 15 – 250 C and relative humidity between 35 – 65%.
2. Heat sources, e.g. radiator or sunlight through windows should be avoided, as localized heating and moisture migration within the capsules may be caused.
3. Storage under or near sources of water, such as condensation on pipes and / or leaking valves should be avoided.
• Capsules should not be subjected to sudden temperature fluctuations and if stored in unheated warehouses, should be allowed to equilibrate with the conditions in the filling area before use.
• The corrugated boxes should be re-sealed if, Quality Control samples are removed from the box.
This is yet another Critical & Very Important stage, unless the packaging and storage conditions doesn’t meet the requirements, the whole process is of no importance.This last stage of the journey begins with the initial packaging of defect free capsules in non-static polyethylene bags of 100 micron thickness to hold sufficient quantity of capsules based on capsule size.
A 30 mm EPS blocks are placed on all 6 sides of the corrugated box to prevent damage of capsules due to moisture penetration and / or excessive heat radiation.
• Domestic Supply : Our Capsules are packed in heavy wall 7 ply virgin Kraft paper corrugated boxes. We supply one size corrugated box for all size of capsules for Domestic supply.
• Export Supply : Export supplies are made by AIR or SEA. In this case the capsules are packed initially in plastic laminated aluminum bags with EPS blocks as escorts to prevent damage to the capsules from moisture and heat. The final corrugated boxes are again wrapped with polyethylene sheet to prevent damage.
• Outer Dimensions : For Domestic Supply : 670 x 480 x 680 mm For Export Supply : 670 x 480 x 730 mm