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PENTAVOX HERBALS – Infrastructure & Highlighting Features

A permanent team of technocrats including Botanists, Pharmacologists, Microbiologists, Pharmacists, Entomologists, Analytical Chemists and above all the experienced Vaidyas (Specialist Ayurvedic Doctors), synergises the system of entire manufacturing operations and quality control headed by Ayurvedacharya Dr Pradeep Nagrath.

A. LOCATION OF FACTORY PREMISES: The production unit is situated in a peaceful and lush green surroundings, absolutely away from open sewage, drainage, public lavatories or any such factories that produces disagreeable or obnoxious odour or fumes or large quantity of soot, dust or smoke and quite a distance away from heavy vehicular noise and air pollution.

B. BUILDING: The ultra-modern building for the factory possesses an advanced structural design conforming to all standards and has been constructed keeping in view the international health law requirements. The entire production is undertaken under extra hygienic conditions. The premises for the manufacturing, processing, packaging, labeling and testing purposes are:

1. Compatible with any other manufacturing operations to be carried out in the same or any other adjacent working area with the factory;

2. Adequately provided with the working spaces to allow orderly and logical placement of machinery, equipment, instruments and other materials so as to: a. completely to avoid the risk of mix-up between different components or processed products;

b. control all possibilities of cross contamination by other components or products and avoid the risk of omission of any manufacturing or control step.

3. Designed for an easy and perfect cleaning, disinfection and sterilisation in such a manner to prevent entry of insects and rodents in the general premises and protect sensitive areas from microbial contaminations;

4. Provided with adequate lighting, ventilation, exhaust and air-conditioning in the sensitive and other requisite areas so as to protect all the components and the products from any adverse effect during processing, formulation and storage and retain accurate functioning of the laboratory instruments; and
5. Provided with concealed electric and sanitary fittings, an underground drainage system and wall-leveled ventilators and air-inlet points.

C. WATER SUPPLY: The water used in the manufacture is of pure and drinkable quality, free from pathogenic micro-organisms and conforming to health laws and FAO/WHO specifications.

D. WASTE DISPOSAL: The wastewater and other residual wastes from laboratory and manufacturing processes are being disposed off after suitable treatment.

E. MANUFACTURING PROCESS: Adequate working space and room has been provided for different stages of manufacturing and their relevant quality control measures to minimise and eliminate any risk of mix-ups and to control the possibilities of cross contamination of one component or product by another stores or handled during pre or post process in the same premises.

Different storage areas for materials ‘under test’, ‘approved’ and ‘rejected’ are provided with arrangements and equipment for drying, cleaning and orderly placement of stored materials and products. The temperature and humidity conditions are controlled both in the working and storage areas.

Access to the manufacturing areas has been restricted to authorized personnel only. Special written procedures are followed for entrance and exit of the entire manufacturing premises which has been dividing into the following:

1. Pre-Storage/Disposal-Point for raw ingredients’ collection and preliminary confirmation of quality or specified standards.

2. Separate stores, ordinary and air-conditioned for the raw materials, packing materials, tools and manufacturing equipment, general consumables and sensitive products.

3. Separate processing sections for each processing stage.

4. Sterlization and radiation chambers.

5. Separate formulation sections for tablets/pills, capsules, oral liquids, medicated oils and external applications, powders, food, cosmetics, traditional products etc.

6. Separate packing and cartooning sections.

7. Separate quality check and control wing accessible to the entire manufacturing process.

8. Continuous Research & Development Wing.

9. Separate stores for finished formulations.

All surfaces in the manufacturing area have been designed to keep the interior surfaces (walls, floors and ceilings) smooth and free from cracks to facilitate an easy cleaning and disinfecting. These areas are periodically checked by competent personnel and records thereof maintained. Routine microbial counts of all sterile areas are carried out before, during or after manufacturing operations and results of which are checked as per WHO standards and records maintained.

F. SANITATION PRE-REQUISITES: It is ensured by proper supervisions that the total manufacturing premises shall:

1. not be utilized for any other purpose;

2. be maintained, cleaned and in orderly manner free from accumulated waste, dust, debris etc.;

3. not be used for general thoroughfare;
4. not be used for storage of any material other than that being processed; and
5. not be used for smoking, chewing or any other unhygienic practices as they are strictly prohibited.

A uniform routine sanitation Programme has been drawn up, being observed and properly recorded and is meant to indicate:

a) the total division of the area into specific areas for cleaning purposes;

b) cleaning intervals;

c) cleaning procedure to be followed including equipment and materials to be used; and

d) personnel assigned to and responsible for cleaning operations.

These records of compliance to the above conditions for sanitation are being maintained properly and are subjected to frequent in-house and regular statutory inspections.

G. PERSONNEL HEALTH, CLOTHING & SANITATION RESPONSIBILITIES INCLUDING DISEASE CONTROL:
No person known to be affected with any communicable disease, known to be a carrier of a communicable disease, known to be afflicted with boils, infected wounds or open sores or known to have an acute respiratory infection is allowed to work in any area of the establishment in any capacity in which there is any likelihood of the person contaminating raw material or contact surfaces with pathogenic organisms or of transmitting disease to other individuals.

All the personnel including temporary staff who come into direct contact with components or products anyhow before, during or after manufacturing processes are required to undergo a periodic health check-up.

Adequate facilities for first-aid, vaccinations and other exigencies, medical examinations at the time of employment and thereafter periodically with particular attention being devoted to freedom from infectious conditions have been provided under the services of a team of qualified physicians. Assessment of health status of personnel involved in the manufacturing and quality control of products is also undertaken efficiently. Records are being maintained properly.

H. CLEANLINESS: Just before entry to the manufacturing or the laboratory, separate change rooms for each sex with facilities for personal cleanliness, hand dryers, disposable towels, disinfectant soaps and hand scrubbing brushes have been provided to enable the personnel to change their street clothes and wash and wear clean factory uniform, headgear, footwear before entering the manufacturing or laboratory zones.

All persons working in direct contact with product preparation, raw ingredients, or contact surface are not at all allowed to transfere the strict requirement of:

a) wearing clean and suitable outer garments while on duty so as to prevent contamination of the components or products;

b) maintaining a high degree of personal cleanliness and conform to hygienic practices while on duty;

c) washing hands thoroughly after each absence from a work station before returning back to prevent soil, chemical or biological contamination to components or products;

d)
sanitizing or wearing sanitary gloves; and

e) taking all necessary precautions to prevent contamination of products with micro-organisms or foreign substances including but not limited to perspiration, hair, cosmetics, tobacco, chemicals and medications.

Besides the above, none of the authorized personnel are allowed to store personal belongings, eat or drink beverages or use tobacco in any form in the entire manufacturing area or in areas where products or ingredients are exposed or in areas used for washing equipment or utensils.

Supervision to assure compliance by all requirements of PENTAVOX GMP has been clearly assigned to competent supervisory personnel.

I. MANUFACTURING EQUIPMENTS: There is a unique combination of traditional and ethnic techniques, instruments and the ultra modern equipments that have specially been designed, fabricated, structured, installed and maintained in a way so as to:

1. achieve operation efficiency to attain the highest quality;

2. prevent physical, chemical and physiochemical change through surface contact;

3. facilitate thorough cleaning whenever necessary;

4. minimise any contamination of components or products and their containers during entire manufacturing process; and

5. prevent contact of any substance required for the operation of the equipment like lubricants etc.

Record of complete technical and operative literatures of each machine, equipment and instrument used for manufacturing processes or laboratory is continuously upgraded and is required to be red by the respective operators, before they commence the job.

Special on-machine practical training is provided to the workers for the smooth handling of even the most sophisticated machines, and this training is being constantly upgraded, through refresher training courses to keep up with the latest technology.

Specific written cleaning and sterilisation instructions to all machinery, equipment, instruments and utensils have been provided and are required to be strictly complied with for their disassembly, cleansing and sterilisation, scheduled in accordance with the instructions, after each manufacturing operation/batch.

Records are being maintained for all periodic checks, including confirmation of accuracy and precision and regular calibrations of:

1. specific filling equipment;

2. premise filling;

3. recording and monitoring device used to evaluate performance of the sterilisation equipment; and

4. monitoring device fitted with alarm system for malfunctions, in the processing equipment, used for recording permanent parameters of critical steps.

J. MASTER FORMULA RECORDS: There are Master formula records relating to all procedures of the manufacturing of each product which has been prepared and endorsed by the competent technical staff i.e. Heads of Product Development, Production, Quality Control and Specialist Ayurvedic Consultants. The master formula record provides the details of:

1. common names and botanical names with specified species of the herbal ingredients or the minerals, if used;

2. the specified references of quantity and quality of the parts or forms of all the therapeutic ingredients and the processing ingredients, separately to be used in the entire manufacturing processes;

3. washing, cleansing and drying procedures;

4. all individual processing stages;

5. formulation and final shaping of the product;

6. all vessels and equipment and the sizes used in the process;

7. manufacturing and control instructions along with details of critical steps and sterilisation procedures;

8. instructions on precautions to be taken during manufacture or storage of finished or semi finished products;

9. the theoretical yield to be expected from the formulation at different stages of manufacture and permissible yield limits;

10. the requirements of in-process quality control tests to be carried out during each stage of manufacture including the designation of persons or departments responsible for the execution of such tests;

11. the requisite controls of room temperature, relative humidity, weight variation, disintegration time, mixing time, homogeneity of suspension, volume filling, leakage and clarity limits; and

12. the description or identification of the final containers, packaging materials, labels and closures to be used.

K. MANUFACTURING OPERATIONS & CONTROLS

The entire manufacturing operations and controls including critical steps relating to selection, weighing and measuring of components during the various stages are being carried out under the direct personal supervision of the competent technical staff.

The contents of all vessels and containers used in manufacture and in-process storage and their mechanical manufacturing equipment during manufacturing operations are conspicuously labeled with the names of the product, batch number, batch size and stage of manufacture.

Special rigid controls are carried out to ensure the products to be free from pathogens like Salmonella, E-Coli, Pyocyanea etc. and periodic Total Plate Count (TPC) are carried out to ensure to keep total aerobic bacteria contents below limits in the product.

Other controls include protection from contamination and cross-contamination from Yeast, Mold and B-lactum for a better shelf life of the products. All vessels or equipment used during the pre and post stages of manufacture are being inspected for presence of foreign matter besides any technical defect by the competent personnel of the Quality Control Department and recorded thereof.

L. LABELLING & PACKAGING
Strict control is being exercised over labeling issued for use in product labeling operations. Labeling are used for products. Access to the printed materials including labels, packaging materials and leaflets is restricted to authorised personnel only and stored, handled and accounted by the procedure incorporating the following features:

1. Prevention of mix-ups and cross contamination by physical or spatial separation from operations on other products.

2. Identification of the products with a lot or control number that permits determination of the history of the manufactured and control of the batch.

3. Examination of packaging labeling materials for suitability and correctness before packaging operations and documents of such examination in the batch production record.

4. Recommendation by the Quality Control Department for the issuance of requisite number of all labels for containers, mono and master cartons and release as satisfactory for use all circulars, inserts and leaflets after duly testing and quality approval.

5. Inspection of packaging and labeling facilities immediately before use to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

6. Investigation of any discrepancy in the number of labeling and packaging units issued and actually packed each time after completion of the labeling and packaging process and before releasing of final batch.

Unused coded and spoiled labels and packaging materials are destroyed under the supervision of Quality Control Department. The records of each shipment received of each packaging material indicating receipt, examination relating to testing and whether accepted or rejected, is maintained.

M. RESPONSIBILITIES OF QUALITY CONTROL DEPARTMENT
The Quality Control Department (QCD) is directly responsible to the management but is independent of all other departments and has the sole responsibility and authority to approve or reject all components, product containers, closures, in-process materials, packaging materials, labeling materials, quality and stability of all finished products, and authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The QCD is responsible for approving or rejecting products manufactured, processed, packed or held under contract by another company.

The QCD is required to keep the record and strict vigil on the inventory of all raw components, intended for use at any stage of manufacturing. All raw components have to be systematically sampled, identified, assigned a control reference number, conspicuously labeled indicating their name, supplier or the manufacturer’s name, specifically labeled for ‘under test’ or ‘approved’ or ‘rejected’, tested for compliance with specified standards of quality and stored at optimum temperatures and relative humidity. All such components are released from Quarantine through written instructions in an organised stock rotation manner of first-in and first-out. All rejected components are conspicuously identified and destroyed or returned to the supplier on top priority basis and records maintained thereof.

The QCD is authorised and required to maintain a proper record for each batch of the entire production wherein a complete manufacturing history of each batch of the finished product, ensuring that it has been manufactured, tested, controlled and analysed in accordance with the manufacturing procedures and written instructions as per the master formula.

The QCD is required to establish, prepare or if required revise the detailed instruction in writing for carrying out all control procedures and specifications by testing or analysing pre-process, during or post process all components and evaluate the adequacy of the conditions under which they are being stored. They also possess the team authority to examine returned products as to whether such products should be released, reprocessed or destroyed. TECHNOLOGICAL ISSUE

In order to assure the quality and reduce the variability in the Ayurvedic formulations, the basic logic to understand the entire manufacturing process and the basic values of all the ingredients; by:

a) having a thorough knowledge and deep technical information (the chemistry, the qualitative and quantitative composition) about active ingredients of herbs and their compatibilities.

b) understanding inter and intra-batch variations in the same plant, including the complex problems of the formulations.

c) sourcing rightly, pollutant/contaminant free herbs (from the cultivation) and controlling the factors of heredity, ontogeny (stage of growth), methods of collection, post harvest, handling at the point of source and storage.

d) ensuring all standard specifications of health by rigidly checking rampant adulteration and substitution in the plant parts, treating them so as to preserve their qualities; and

e) validating dosage form’s manufacturing process subjecting to various n-process controls developed by Research & Development levels and final preparations to rigid quality control testing.

It is extremely important to go for systematic:
1. Standardisation of raw material

2. Validated process of manufacture

3. Validated manufacturing equipment

4. Stringent environmental controls.

N. RAW MATERIALS
The raw ingredients are standardised by in-house Research, Development, Analytical and Quality Control labs for all kinds of Ayurvedic/Herbal formulations. Various physical, chemical and biological tests are conducted for the botanical and biochemical identification of the raw ingredients to ascertain their quality and detect adulterations. This system not only provides the authentic samples but also assists in analysing and determining the level of authenticity.

‘Multi Point’ and ‘Multi Stage’ controls are also carried out to check the prescribed limits on the extraneous impurities (heavy metals, pesticidal residues, foreign matter, animal excreta, abnormal colour, odour, sliminess, mould, other evidences of deterioration etc.).

A preliminary raw material protocol includes:
1. Optimum collection time according to maturity specifications of herbs;

2. Correct botanical identification (order, genus, species, variant);

3. Quality and purity of herb;

4. Chemical composition;

5. Determination of the active principle;

6. Identification and quantification of adulterants and substitutes;

7. Efficacy of the drug;

8. Presence and concentration of toxins and aflatoxins; and

9. Specific storage conditions.

The standardisation procedure includes:
1. Morphological studies i.e. gross morphology (entire product), cyto-morphology (cell) and particle level studies.

2. Organoleptic evaluation i.e. evaluating odour, taste, colour and texture oof the product.

3. Preliminary identification tests include in-house standardised cytomorphological, microscopic examination, submicroscopic structural evaluations through refractive indices and optical rotation, physical parameters of solubility; dye tests; determination of ash, moisture, essential oil contents etc.

4. Advanced identification tests begin with Chromatographic Techniques to separate complex mixtures for isolation of the active constituent.