|Name & Address
ACG Associated Capsules Pvt.Ltd. Plot.No.M29-44,Pharma Zone,Special Economic Zone (SEZ) Phase II,Pithampur,Dist.Dhar, Madhya Pradesh- 454775,India
Mr. Yogesh Mahanubhav
Manager - Quality Assurance
The site is located in a pollution free environment away from potential sources of dust; smoke foul odours and other types of contamination. The manufacturing facility is designed, constructed and maintained to facilitate the manufacturing of hard capsule shells under hygienic conditions. It conforms to the conditions laid down in the Factories Act 1948.
A specific quantity of material produced in a series of processes and expected to be homogeneous within specified limits.
Minimum: 10 lacs, Maximum: 100 lacs for Domestic & Rest of the World (ROW).
Minimum: 1 million, Maximum: 10 millions for USA & Europe.
Define batch numbering system?
A typical batch number consists of 10 digits, where first 4 digits indicate the manufacturing location while the remaining 6 digits are system generated (SAP) serial numbers incremented by 1 for next batch.
1100 - Dahanu location
1110 - Kandivali location
1120 - Shirwal location
1150 - Pithampur location
4100 - ACG Lukaps location
Personnel suitably qualified through education, experience and training are engaged in the manufacturing, processing, packaging, distribution and quality assessment of empty capsules.
All new employees are put through an induction program of appropriate duration depending upon their grade, position and nature of work. Departmental orientation is provided by the HOD and section in charge.
Training on GMP, hygiene, sanitation and SOPs is conducted for all employees whose work impacts quality of the product. In addition personnel are counselled and trained on safety practices, fire fighting and first aid.
Training needs of management and supervisory personnel are identified by the HODs based on qualifications, experience and nature of responsibilities. Management personnel are also evaluated annually for performance and any evident training needs identified. Training needs for each category of workmen and staff are identified by HODs as per the nature of work carried out. These are recorded in the training need identification form.
A training calendar for internal and external training is drawn to incorporate training for all identified needs and training is provided. Hands on experience is given where necessary. Evaluation is done through objective test or on the job observation and this forms the basis for identification of retraining needs. Training details are recorded in the individuals training card which is maintained by HR department in the employees personal file.
A written housekeeping program is set up, assigning responsibility for sanitation. It outlines the cleaning schedules, methods, equipment and materials to be used in cleaning. Only approved cleaning and sanitizing agents are used.
The entire factory has been grouped into following categories:
- Critical areas: Mucilage preparation, Hard Capsule Machines & Printing
- Important areas: General stores, Final Quality Control Dept., Finished goods store, Work In Progress site, Production corridors and immediate surrounding areas, staircases, laboratory etc.
- Service Areas: Non - production corridors, offices, canteens etc.
- Surrounding: Compounds, Utilities etc.
Cleaning involves a general cleaning for all non-critical areas & specialized cleaning for critical areas.
General cleaning for non-critical areas are done by using wet mopping with disinfectant solution such as solution Phenyl for general cleaning & Sodium Hypochlorite (2%) in change room.
Specialized cleaning for critical areas are done by using mopping with disinfectant solution such as Virosil, Polysan, Protasan, Sumabac, Sodium Hypochlorite.
Compositions are provided below:
- Virosil - Hydrogen Peroxide stabilized with Silver ions.
- Polysan - Iodophor containing tamed Iodine.
- Protasan - Fatty alcoholethoxylate, Quaternary Ammonium compounds, Benzyl - C12 - 16 - Alkyldimethyl Chlorides, Editic acid, Betain.
- Sumabac - Alkyldimethylbenzyl ammonium chloride, Alkylalcohol Ethoxylate, Sodium carbonate.
A Pest Control Program encompasses the entire facility and premises on a regular basis to prevent any insect or rodent infestation.
Pest control is done to keep the factory free from pests, rodents and insects. Quotations are invited from various pest control agencies and they are short listed on the basis of their performance and experience. A contract is signed with the agency to undertake pest control as per technical agreement.
The effectiveness of pest control is monitored fortnightly. In case of ineffectiveness, the agency is called for investigation of cause and corrective action / measures are implemented.
Flycatchers are installed in all critical areas. Cleaning of insectocutors is done once 15 days.
Preventive maintenance program
The maintenance department in conjunction with the user departments is responsible for maintenance of production and testing equipment. Preventive maintenance schedules are drawn for hard capsule manufacturing machine and accessories, gelatin room equipment and capsule printing machines based on their impact on equipment continuity and product quality. These are implemented and monitored.
Process Validation is defined as the process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
Before process validation can begin, the facilities, equipment, and utilities that will be employed for the process validation activities must themselves be qualified.
Analytical testing methods are validated. Staff taking part in the validation work are appropriately trained.
We perform stability study at following condition as per ICH guidelines and conducted on 3 batches per year.
- Long term stability study: Recommended storage condition of Hard Capsules Shells, Room temperature between 15°C to 30°C and 40% to 65% RH.
- Short term stability study: 30°C ± 2°C and 65% RH ± 5 %.
Who has responsibility for releasing raw materials, packaging materials, intermediates, finished goods and what is the routine procedure for these activities(e.g.ID test etc.)?
Raw materials, packaging materials, intermediates & finished goods are tested by QC chemist & approved by Head QA in SAP.
Test data is entered into SAP. QA responsible person reviews the data & BMR & releases the materials by giving usage decision in SAP.
Is release process via a validated computer system?
Yes validation report no VR/PQ/SAP/01/01 dated 28/1/12.
Describe customer complaint handling?
Customer complaints are received by sales team and recorded in the SAP system from where they are forwarded to QA. Complaint is investigated, evaluated and a corrective action is identified. Customer is informed regarding the outcome and corrective action initiated to prevent reoccurrence.
Identify area of Improvement (Seek Approval)
Authorize Trials (Release trial approval )
Conduct Trials as applicable and Validate
Inform customer through formal change control for significant changes which may affect product quality
Monitor & Review changes implemented
Handling of nonconforming products
Nonconforming raw material, packaging material, in process material and finished product are identified, documented and segregated to prevent their inadvertent use.
Nonconforming material is disposed off by one of the following ways as appropriate and concern functions are notified
a) Rework to meet the specified requirements
b) Accept with or without rework by concession
d) Scrap or reject
Non conforming products are isolated physically as well as by computers
Handling of out of specification
In the event that a result of a test does not conform to specifications, when performed for the first time, describe what action is taken.
1) Immediate supervisor is informed.
2) OOS investigation starts as per OOS SOP and protocol.
3) Retests are performed if OOS result is invalidated by evidence. Retest is performed on the same sample.
4) Production review done if no assignative cause is found.
1) Planned deviations involving change in process or systems are handled through Change Control and monitored.
2) In case of unplanned deviation (e.g. Power fluctuations in Mfg. Area) the person who observes the deviation informs the observation immediately to his Supervisor. Supervisor inform HOD-QA and raise the deviation form. HOD- QA or his representative visits the site of deviation and record their observations. Cause of deviation is investigated and actions are planned for correction of the same.
Completions of correction activities are monitored.
What percentage of your business is for the pharmaceutical & nutraceuticals?
80% for pharmaceutical and 20% for nutraceuticals.
Retention period for preserved samples & batch records?
Are you division or subsidiary of another company?
Yes, we are division of ACG Worldwide.
Production capacity utilization
1961 - Kandivli
1983 - Dahanu
1997 - Shirwal
1981 - ACG Lukaps
2013 - Pithampur
Hard Gelatin Capsule Shells
Dahanu - 20.31 billion per annum
Kandivli - 16.85 billion per annum
Shirwal - 19.97 billion per annum
Pithampur - 23.64 billion per annum
ACG Lukaps - 8.43 billion per annum
Total - 89.22 billion per annum
Cellulose Capsule Shells
Dahanu - 2.23 billion per annum
Pithampur - 6.03 billion per annum
Total - 8.27 per annum
Last date of FDA inspection by local authority
Dahanu – 17 August 2016
Shirwal – 16 November 2016
Kandivli – 31 January 2017
ACG Lukaps – 11 September 2014
Pithampur - 07 July 2015